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Purpose: This study was aimed to examine the structural and construct validity of the Italian version of the Yale Food Addiction Scale in a multisite sample of postgraduate students., Methods: Two hundred and fifty-six subjects (78.1% females) aged from 18 to 53 years (mean = 23.93, SD = 4.96) and attending different postgraduate university programs at multiple Italian universities completed the Italian YFAS, the Italian Binge Eating Scale (BES), the Italian Eating Attitudes Test-26 and the Italian Dutch Eating Behavior Questionnaire (DEBQ) online through Qualtrics., Results: Confirmatory Factor Analysis showed that the single-factor model of the Italian YFAS including all original items had adequate fit indexes (χ 2 252 = 454.183; p < 0.001; normed χ 2  = 1.802; RMSEA = 0.056; 90% CI 0.048-0.076; CFI = 0.761; WRMR = 1.592). However, item analysis revealed that item#25 had zero variance (all subjects were assigned the same score after item dichotomization) and item#24 had a low factor loading, and were thus removed. Furthermore, item#10 and item#11 showed to be almost perfectly correlated (r = 0.998) and were thus parceled. The resulting 19-item single-factor model revealed a better fit to the data (χ 2 152 = 235.69; p < 0.001; normed χ 2  = 1.556; RMSEA = 0.046; 90% CI 0.034-0.058; CFI = 0.858; WRMR = 1.236) and its internal consistency was acceptable (KR-20 = 0.72). Also, a single-factor model including the seven diagnostic symptoms was tested and showed adequate fit values (χ 2 20 = 41.911; p < 0.003; normed χ 2  = 2.09; RMSEA = 0.065; 90% CI 0.037-0.093; CFI = 0.946; WRMR = 1.132). Statistically significant and small-to-high correlations were found with all convergent measures, in particular with the BES., Conclusion: The Italian 19-item YFAS resulted to be a valid and reliable tool for the assessment of food addiction in postgraduate students., Level of Evidence: Level V, descriptive study.

Obesity is the result of a complex interplay among several factors leading to medical, functional and psychosocial consequences that markedly reduce life expectancy and impair quality of life. Is obesity itself a disease? Is obesity a brain disease? Who should treat obesity? This paper is a narrative review aimed to describe and to argue the prevalent position of some major Italian scientific and academic institutions dealing with obesity. According to the recent statements and recommendations published by the Italian Society for Obesity (SIO) and the Italian Society for the Study of Eating Disorders (SISDCA), the management of obese patients should include five main levels of care: (1) primary care, (2) outpatient treatment, (3) intensive outpatient treatment, (4) residential rehabilitative treatment, and (5) hospitalization. Ideally, patients suffering from obesity need a multidimensional evaluation intended to design an individualized treatment plan applying different procedures and therapeutic strategies (diet, physical activity and functional rehabilitation, educational therapy, cognitive-behavior therapy, drug therapy, and bariatric surgery). This thorough approach should address not only weight loss but also quality of weight loss, medical and psychiatric comorbidity, psychosocial problems, and physical disability. Such management of obesity requires an effective multiprofessional team, while health services have to overcome a number of administrative and organizational barriers that do not account for diseases requiring resources and professionals from different areas of medicine. Integrating several competences in a team-based approach demands specific education, skills and expertise. As for other diseases, the principles of complexity theory may offer a model useful to implement both teamwork and care delivery for patients with obesity.

Personality traits can affect eating behaviors, the development of obesity, and obesity treatment failure. We investigated the personality characteristics and their relation with disordered eating in 586 obese women consecutively seeking treatment at eight Italian medical centers (age, 47.7±9.8 years) and 185 age-matched, normal weight women without symptoms of eating disorders (Eating Attitude Test<20). The assessment included anthropometry, the Temperament and Character Inventory (TCI), the Binge Eating Scale (BES) and the Night Eating Questionnaire (NEQ). Logistic regression analyses were carried out in different models with BES score≥27 and NEQ≥30 as dependent variables and TCI scores as independent factors. Personality traits of obese individuals included significantly lower self-directedness and cooperativeness on TCI. BES and NEQ scores were higher in obese women, and values above the defined cut-offs were present in 77 and 18 cases (14 with high BES), respectively. After controlling for age and BMI, high BES values were associated with high novelty seeking and harm avoidance and low self-directedness, the last two scales being also associated with high NEQ. We conclude that personality traits differ between obese patients seeking treatment and controls, and the presence of disordered eating is associated with specific personality characteristics., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

This paper is an Italian Expert Consensus Document on multidimensional treatment of obesity and eating disorders. The Document is based on a wide survey of expert opinion. It presents, in particular, considerations regarding how clinicians go about choosing the most appropriate site of treatment for a given patient suffering from obesity and/or eating disorders: outpatient, partial hospitalization, residential rehabilitation centre, inpatient hospitalization. In a majority of instances obesity and eating disorders are long-term diseases and require a multiprofessional team-approach. In determining an initial level of care or a change to a different level of care, it is essential to consider together the overall physical condition, medical complications, disabilities, psychiatric comorbidity, psychology, behaviour, family, social resources, environment, and available services. We first created a review manuscript, a skeleton algorithm and two rating scales, based on the published guidelines and the existing research literature. As the second point we highlighted a number of clinical questions that had to be addressed in the specific context of our National Health Service and available specialized care units. Then we submitted eleven progressive revisions of the Document to the experts up to the final synthesis that was approved by the group. Of course, from point to point, some of the individual experts would differ with the consensus view. The document can be viewed as an expert consultation and the clinical judgement must always be tailored to the particular needs of each clinical situation. We will continue to revise the Document periodically based on new research information and on reassessment of expert opinion to keep it up-to-date. The Document was not financially sponsored.

Background: Obesity is a major problem especially in western countries and several studies underline the importance of physical activity to enhance diet. Currently there is increasing interest in instruments for monitoring daily physical activity. The purpose of this pilot study was to appraise the qualitative and quantitative differences in physical activities and gait analysis parameters in control and obese subjects by means of an innovative tool for the monitoring of physical activity., Methods: Twenty-six obese patients, 16 women and 10 men, aged 22 to 69 years with Body Mass Index (BMI) between 30 and 51.4 kg/m2, were compared with 15 control subjects, 4 men and 11 women, aged 24 to 69 with BMI between 18 and 25 kg/m2 during daily physical activities. The IDEEA device (Minisun, Fresno, CA), based on a wearable system of biaxial accelerometers and able to continuously record the physical activities and energy expenditure of a subject in time was used. Time spent in different physical activities such as standing, sitting, walking, lying, reclining, stepping, energy expenditure and gait parameters (velocity, stance duration, etc) were measured during a 24-hours period., Results: A trend toward a reduced number of steps was present, associated to reduced speed, reduced cadence and reduced rate of single and double limb support (SLS/DLS). Moreover, obese people spent significant less time stepping, less time lying and more time in a sitting or reclined position during the night. The energy expenditure during a 24-hours period was higher in the obese compared to controls., Conclusions: The study provided objective parameters to differentiate the daily motor activity of obese subjects with respect to controls, even a larger population is required to confirm these findings. The device used can be of support in programming educational activities for life style modification in obese people as well as for monitoring the results of various kinds of intervention in these patients concerning weight and physical performance.

Background and Aims: Lifestyle changes are considered first line treatment in type 2 diabetes, but very few data are available in the "real world" of diabetes units. We aimed to measure the effectiveness of moderate and high intensity interventions on weight loss, metabolic control and insulin use. We report a prospective cohort study, carried out in 822 consecutive subjects with type 2 diabetes, first seen in a 4-year period in a diabetes unit of an academy hospital., Methods and Results: Subjects were treated with either a sole prescriptive diet (Diet), or received an additional short-course Elementary Nutritional Education (4 group sessions-ENE) or an intensive Cognitive Behavioural Therapy (12-15 group sessions-CBT). The results were adjusted for the propensity score to be assigned different treatments, derived from logistic regression on the basis of age, gender, BMI, HbA1c, diabetes duration and insulin use at baseline. Main outcome measures were weight loss and weight loss maintenance, metabolic control, and secondary failure to insulin use. Both structured programmes produced a larger weight loss, and the adjusted probability of achieving the 7% weight loss target was increased. Similarly, both programmes favoured metabolic control, irrespective of insulin use. After adjustment for propensity score, both ENE (hazard ratio, 0.48; 95% CI, 0.27-0.84) and CBT (hazard ratio, 0.36; 95% CI, 0.16-0.83) were associated with a reduced risk of de novo insulin treatment., Conclusion: Structured behavioural programmes aimed at lifestyle changes are feasible and effective in the "real world" setting of a diabetes unit for the treatment of type 2 diabetes.

Objective: We aimed to investigate the association of the clinical variables of the metabolic syndrome (MS) and psychological parameters on health-related quality of life (HRQL) in obesity. In particular, our aim was to investigate the relative impact of physical symptoms, somatic diseases and psychological distress on both the physical and the mental domains of HRQL., Design: Cross-sectional study., Subjects: A cohort of 1822 obese outpatients seeking treatment in medical centers., Measurements: HRQL was measured by the standardized summary scores for physical (PCS) and mental (MCS) components of the Short Form 36 Health Survey (SF-36). Patients were grouped according to tertiles of PCS and MCS. Metabolic and psychological profiles of PCS and MCS tertiles were compared by discriminant analysis., Results: The profile of metabolic and psychological variables was tertile-specific in 62.4 and 68.3% of patients in the lowest and highest tertiles of PCS, respectively, while concordance was low in the mid-tertile (32.8%). Concordance was very high in the lowest (74.4%) and in the highest (75.5%) tertiles of MCS, and was fair in the mid-tertile (53.2%). The main correlates of PCS were obesity-specific and general psychological well-being, BMI, body uneasiness, binge eating, gender and psychiatric distress. Only hypertension and hyperglycemia qualified as correlates among the components of MS. The components of MS did not define MCS., Conclusions: Psychological well-being is the most important correlate of HRQL in obesity, both in the physical and in the mental domains, whereas the features of MS correlate only to some extent with the physical domain of HRQL.

Objective: To investigate the construct validity of the Short Form-36 (SF-36) Health Survey questionnaire in obese patients., Research Methods and Procedures: Our series consisted of 1735 obese patients (age, 44.7 +/- 11.0 years; 1346 women) consecutively enrolled in the QUOVADIS study, an observational multicenter study of obese treatment-seeking outpatients. The construct validity of the SF-36 was assessed by main component analysis. Age-, gender-, and education-adjusted general linear models were used to investigate the relationship between BMI and SF-36 domains or factors identified by main component analysis., Results: BMI was significantly associated with poor health-related quality of life in all eight SF-36 domains, and the strongest association was observed with physical activity. Main components analysis generated a six-factor solution explaining 59% of the observed variance. BMI was strongly associated with factors based on the loading of items regarding the physical activity domain and factors based on role-physical and role-emotional items or general health and bodily pain items. In contrast, mental health-, vitality-, and social functioning-based factors were not related to BMI., Discussion: In obese treatment-seeking outpatients, the clustering of SF-36 items in main components is not significantly different from the domain-based approach generally used, thus confirming the robustness of such a generic questionnaire in this specific condition. However, the peculiar clustering of some SF-36 items and their relationship with BMI suggest that the health-related quality of life profile of subjects belonging to that population may be better described with alternative aggregations of the SF-36 items or with disease-tailored questionnaires.

Educational programs are reported to improve metabolic control and well-being in Type 1 diabetes mellitus (DM), but the effects of newly- structured interventions, aimed at promoting empowerment in educated patients in active selfcare, have received little attention. Ninety patients with Type 1 DM in intensive insulin treatment were invited to an empowerment-based educational intervention. Changes in quality of life and psychological well-being in the 54 patients participating in the program (median age, 44 yr) were compared with those measured in patients who refused. The following questionnaires were administered at baseline and 12 months later: Psychological General Well-Being (PGWB), Medical Outcome Survey Short-Form 36 (SF-36), and Well-Being Enquiry for Diabetics (WED). Baseline values were indicative of moderate, but significant, psychological distress in the whole cohort. At follow-up, the experimental group had a better metabolic control {glycosylated hemoglobin, -0.4% [time x treatment analysis of variance (ANOVA), p = 0.005 vs controls]}, and a general improvement in comprehensive indices and most scales of PGWB and SF-36. Vitality (p = 0.042) and Social Functioning (p = 0.039) were no longer different from population norm. Similarly, the Symptoms (p = 0.005), Discomfort (p = 0.043) and Impact scales (p = 0.032) of WED, reflecting physical functioning, diabetes-related worries and familial relationships, role functioning and social network, improved significantly in treated patients. An educational empowerment-based intervention significantly improves the psychosocial aspects of diabetes and quality of life also in patients in active and effective self-care. Repeated educational interventions are the way towards a normal life with Type 1 DM.

Objective: To investigate the effects of a specific program to implement physical activity (fitness program) on weight loss maintenance, activity level and resting energy expenditure (REE)., Design: Observational study of subjects completing a behavioral program., Subjects: In total, 200 overweight/obese subjects (36 males, aged 20-66 years; average BMI, 35.2 kg/m2). Program and measurements:The fitness program consisted of 12 bimonthly sessions, chaired by doctors and dietitians, involving groups of 8-12 subjects. Patients entered the program approximately 9 months after the end of behavioral treatment, during a weight loss maintenance period. The goal was set at a light-to-moderate daily physical activity (brisk walking), quantitatively measured by a pedometer; REE was measured before and after the fitness program by indirect calorimetry in a subset of patients., Results: The fitness program restarted the process of weight loss in over 60% of subjects. At the end of the study, 84% of patients walked at least 5000 steps per day, compared with 24% at the beginning of the study. The probability of losing from 5 to 10% of initial body weight increased by 20% for any 1000 steps/day (OR, 1.20; 95% CI (confidence interval), 1.07-1.35), and that of losing more than 10% by over 30% (OR, 1.33; 95% CI, 1.19-1.49). REE increased significantly by 100 kcal/day (+7.5%), in spite of further weight loss (-1.8%)., Conclusion: A specific fitness program in the weight maintenance phase after a behavioral program may significantly improve the long-term control of obesity.

Background: A comprehensive lifestyle approach is suggested as first-line treatment for the individual features of the metabolic syndrome, but the results in community medicine are usually discouraging. No study has tested the feasibility of an integrated approach between general practitioners (GPs) and specialist centers., Methods: We report the process analysis on baseline data of a randomized study based on the integration between GPs, selecting patients on the basis of a pre-defined grid and specific targets, and a specialist center, providing informative material and arranging courses of counseling and cognitive-behavioral therapy, using a shared database. After initial visits by GPs for clinical assessment and motivation to treatment, patients were randomly assigned to: (a) prescriptive diet, managed by GPs; (b) counseling (four group lessons); (c) cognitive-behavioral treatment (12 group lessons), both managed by specialist center. Data of the first 503 subjects were compared with those of 139 cases self-referring to the specialist center for the treatment of obesity., Results: Subjects enrolled by GPs were more frequently males, had lower obesity grades, and a higher number of features of metabolic syndrome, compared with the control group. Only 10% of subjects randomized to counseling and 27% randomized to behavior declined participation in the intensive treatments; attendance at sessions averaged 90%. GPs were satisfied with their participation and reported that treatments met patients' needs., Conclusions: An integrated approach to lifestyle changes between GPs and a specialist center is feasible in the metabolic syndrome and may be cost-effective, considering the high burden of disease.

We evaluated the prevalence of disordered eating behavior in 168 unselected outpatients with type 2 diabetes mellitus (T2DM) and the effects on the health related quality of life (HRQL). Subjects in generally good glycemic control, treated by diet or oral hypoglycemic agents (58% M; 63.8+/-SD 10.1 years; BMI, 29.7+/-5.9 kg/m2) completed self-administered questionnaires for HRQL (SF-36) and eating behavior [(Three-Factor Eating Questionnaire (TFEQ); Binge Eating Scale (BES)]. Data on HRQL were computed as effectsizes in comparison to population norm. The prevalence of altered TFEQ scales was not different between genders, and varied between 22.1% (disinhibition) and 41.4% (restriction), but only 6.7% had a positive BES score. Age (OR, 0.58 for decade; 95% CI, 0.39-0.87), duration of diabetes (OR, 1.33 for 5 years; 1.01-1.74) and BMI (OR, 1.11; 1.04-1.18) were predictive for the presence of disinhibition. BMI also predicted hunger (OR, 1.16; 1.08-1.25). SF36 domains were not different in relation to positive BES. Disinhibition at TFEQ was significantly associated with poor social functioning (p=0.018) and role-emotional (p=0.022), whereas hunger was associated with poor physical functioning (p=0.010), role-physical (p=0.0014), social functioning (p=0.015) and role-emotional (p=0.0001). Metabolic control, duration of diabetes, and the presence of complications were not associated with HRQL. A disordered eating behavior may be present in T2DM patients, and is associated with poor HRQL. This condition must be considered for an olistic approach to weight control.

Objectives: To investigate weight loss and reasons for attrition in obese patients on long-term continuous care., Design: Observational study with 36 months of follow-up. Setting. Fifteen Italian obesity centres applying a continuous care model of medical treatment., Subjects: One thousand treatment-seeking obese subjects (785 females, median age 45.1 years, median BMI 37.4 kg m(-2)). Weight loss expectations were systematically recorded at baseline., Interventions: An initial intensive treatment period (3-6 months) was followed by a less intensive continuous care (a follow-up control every 2-4 months). Main outcome measures. Attrition, reasons for treatment interruption and BMI change. Data were recorded by telephone interview in dropouts., Results: Only 157 patients (15.7%) were in continuous treatment at 36 months. The main reasons of attrition were logistics, unsatisfactory results and lack of motivation. The only basal predictor for continuous care was lower Expected One-Year BMI Loss (P = 0.016). The probability of dropout increased systematically for any 5% expected BMI loss (Hazard ratio, 1.05; 96% confidence interval, 1.01-1.09). The mean percentage weight loss was greater in continuers (5.2% vs. 3.0% in dropouts; P = 0.016). However, the dropouts satisfied with the results or confident to lose additional weight without professional help reported a mean weight loss of 9.6% and 6.5% respectively., Discussion: Continuous care produces long-term weight loss only in a subgroup of obese patients seeking treatment in medical centres. The finding that subgroups of dropouts report long-term weight loss has implication for the treatment of obesity.

Objective: To investigate weight loss expectations (expected 1-year BMI loss, dream BMI, and maximum acceptable BMI) in obese patients seeking treatment and to examine whether expectations differ by sex, weight, diet and weight history, age, psychological factors, and primary motivations for weight loss., Research Methods and Procedures: 1891 obese patients seeking treatment in 25 Italian medical centers (1473 women; age, 44.7 +/- 11.0 years; BMI, 38.2 +/- 6.5 kg/m2) were evaluated. Diet and weight history, weight loss expectations, and primary motivation for seeking treatment (health or improving appearance) were systematically recorded. Psychiatric distress, binge eating, and body image dissatisfaction were tested by self-administered questionnaires (Symptom CheckList-90, Binge Eating Scale, and Body Uneasiness Test)., Results: In 1011 cases (53.4%), 1-year expected BMI loss was > or = 9 kg/m2, dream BMI was 26.0 +/- 3.4 kg/m2 (corresponding to a 32% loss), and maximum acceptable BMI was 29.3 +/- 4.4 kg/m2 (-23%). BMI and age were the strongest predictors of weight goals. Weight loss necessary to reach the desired targets was largely in excess of weight loss observed during previous dieting. Psychiatric distress, body dissatisfaction, and binge eating did not predict weight loss expectations. The primary motivation for weight loss was concern for future or present health; women seeking treatment to improve appearance had a lower grade of obesity, were younger, and had first attempted weight loss at a younger age., Discussion: Obese Italian patients had unrealistic weight loss expectations. There were significant disparities between patients' perceptions and physicians' weight loss recommendations of desirable treatment outcome.

Objective: To determine parameters of weight history useful for the assessment of weight cycling and their association with psychological distress and binge eating., Design: Cross-sectional., Subjects: A total of 1889 treatment-seeking obese subjects, enrolled by 25 Italian centers (78% female subject), aged 20-65 y (median 45); 1691 reported previous efforts to lose weight (median age of first dieting, 30 y)., Measurements: The number of yearly attempts to lose weight, weight gain since age 20 y, cumulative weight loss and gain were checked by a predefined structured interview. Psychological distress was tested by means of Symptom Check-List 90 (SCL-90), Binge Eating Scale (BES) and Three Factor Eating Questionnaire (TFEQ)., Results: Differences in anthropometric, clinical and psychological parameters were observed in relation to previous attempts to lose weight. Patients in the upper quartile of parameters of weight history were considered weight cyclers. In multivariate logistic regression analysis, after correction for age, sex and BMI, a high BES score was the only factor systematically associated with a high frequency of dieting (OR, 1.70; 95% confidence interval, 1.22-2.36; P=0.022), with higher cumulative weight loss (1.42; 1.12-1.80; P=0.003) and cumulative weight gain (1.38; 1.06-1.79; P=0.017). However, the sensitivity, specificity and positive predictive value of a high BES score were very low to detect cyclers. Weight cycling did not carry a higher risk of complicating diseases., Conclusions: Weight cycling is associated with psychological distress, and binge eating independently increases the risk, but cannot be used to predict cycling. Also, obese patients who do not experience overeating as a loss of control discontinue treatment or regain weight following therapy.

Obesity is a major risk factor for several metabolic diseases, frequently clustering to form the metabolic syndrome, carrying a high risk of cardiovascular mortality. We aimed to assess the prevalence of the metabolic syndrome in treatment-seeking obese subjects and the potential protective effect of physical activity. A cross-sectional analysis of data from a large Italian database of treatment-seeking obese subjects was performed. The metabolic syndrome was defined according to the criteria provisionally set by the National Cholesterol Education Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, based on waist circumference, fasting glucose, triglyceride (TG) and high-density lipoprotein-cholesterol (HDL-C) levels, and arterial pressure. Data were available in 1,889 Caucasian subjects, 78% females, from 25 obesity centers. Minimum criteria for the metabolic syndrome were fulfilled in 53% of cases. The prevalence increased with age and obesity class and was negatively associated with participation in a structured program of physical activity (odds ratio, 0.76; 0.58 to 0.99; P =.041), after correction for age, sex, and body mass. The prevalence of cardiovascular disease was higher in subjects with the metabolic syndrome. A subset of 12.8% of cases had no metabolic abnormalities. They had a lower prevalence of abdominal obesity and cardiovascular disease. Isolated obesity was significantly associated with physical activity (odds ratio, 1.86; 1.33 to 2.60; P =.0003). Multiple metabolic disorders are present in most obese patients, and their prevalence is lower in physically active subjects. It is time to move towards a more integrated approach and to reconsider resource allocation to improve lifestyle changes for large-scale control of obesity.

Aims: Different criteria have been proposed by the World Health Organization (WHO) and by the Third Report of the National Cholesterol Education Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATPIII) for the diagnosis of the metabolic syndrome. Its identification is of particular importance for coronary risk assessment., Methods: The prevalence of the metabolic syndrome was determined according to the two different proposals in 1569 consecutive subjects with Type 2 diabetes., Results: By the WHO proposal, 81% of cases (95% confidence interval, 79-83) were labelled as metabolic syndrome. Microalbuminuria had the highest specificity (99%) and visceral obesity the highest sensitivity (93%). Seventy-eight per cent of patients (95% CI, 76-80) fulfilled the ATPIII criteria for metabolic syndrome, low HDL-cholesterol having the highest specificity (95%), elevated blood pressure having the highest sensitivity. According to both proposals, 1113 patients were positive; 183 were concordantly negative, indicative of a fairly good agreement (k statistics, 0.464). Subjects only positive for the WHO proposal were more frequently males, had a lower BMI and a higher arterial pressure. Only subjects identified by the ATPIII proposal had a significantly higher prevalence of previously detected coronary heart disease., Conclusions: Minimum criteria for the metabolic syndrome are met in most patients with Type 2 diabetes. Correct identification of the syndrome is important for an integrated approach to reduce the high costs and the associated disabilities. The ATPIII proposal more clearly identifies the burden of coronary heart disease associated with the metabolic syndrome.

The clinical significance of liver disease is frequently underestimated in patients with metabolic disorders. In patients followed up in a metabolic unit for diabetes, obesity or hyperlipidemia (n=147), we studied the prevalence and the severity of liver disease, and its relationship with the metabolic syndrome (MS). Cases cared for in a liver unit (n=179) were used as controls. Patients in the metabolic series were older and had a higher prevalence of coronary heart disease. Criteria for the metabolic syndrome were fulfilled in 64% and 22% of cases, respectively (P<0.0001). Liver biopsy was obtained in 44 and 66% of cases. Metabolic patients had a more severe steatosis score (P<0.0001), whereas the scores of fibrosis and necroinflammation were less severe (P=0.0059 and 0.0007, respectively). Histological criteria for non-alcoholic steatohepatitis (NASH) were present in 82% of metabolic cases and 68% cases in the liver series (P=0.057). Liver disease in patients routinely cared for in metabolic units is similar to that observed in patients cared for in liver units, and potentially may progress to terminal liver failure. Liver biopsy is recommended for diagnostic and prognostic purposes, as well as for testing treatment effects in controlled trials.

Several physiological and pathophysiological conditions, including changes in body fat, food intake, and insulin resistance, are known to be associated with variations in plasma ghrelin concentrations. We tested the hypothesis that insulin resistance exerts a primary role by measuring ghrelin in 86 patients with nonalcoholic fatty liver disease (NAFLD), a condition in which insulin resistance is relatively independent of obesity. Compared with 40 matched healthy subjects, patients with NAFLD had similar glucose levels and higher plasma insulin and insulin resistance [homeostasis model assessment (HOMA)-R index] by over 60%. Ghrelin was reduced (mean +/- SD, 226 +/- 72 pmol/liter in NAFLD vs. 303 +/- 123 in controls; P < 0.0001). In relation to quartiles of body mass index, ghrelin progressively decreased in controls (P = 0.003), but not in patients (P = 0.926). In relation to quartiles of HOMA-R, ghrelin decreased in both groups, and significantly correlated with HOMA-R. After adjustment for age and sex, HOMA-R was the sole factor significantly associated with low ghrelin in the whole group (odds ratio, 5.79; 95% confidence interval, 2.62-12.81; P < 0.0001) and specifically in NAFLD (2.96; 1.12-7.79; P = 0.028). The study suggests that insulin resistance is a major factor controlling ghrelin levels in subjects with and without NAFLD.

The burden of obesity on patients' everyday life is high; obese subjects perceive a poor Health-Related Quality of Life (HRQL) in both physical and mental dimensions. We aimed to identify the areas of everyday life limited by health status and factors mainly responsible for perceived problems. The Nottingham Health Profile questionnaire (NHP) was used in 274 obese subjects seeking treatment at a university-based obesity center. Values were compared with normative Italian data, corrected for age and sex. Anthropometric and clinical data were also recorded, and correlated with health status. All domains of NHP were significantly impaired in obesity, the effect size ranging from 0.14 (Emotional Reactions; p = 0.02) to 0.99 (Physical Mobility; p < 0.0001), and varying in relation to gender, age and obesity class. Female subjects reported a higher-than-expected prevalence of problems in most areas of daily life [from 20% (Paid Employment) to 44% (Jobs around the home), compared with 14-26% in controls]. Males reported a high prevalence of problems in Sex life (31%), Holidays (37%) and Hobbies (49%), compared with 14, 14, and 16% in controls, respectively. Logistic regression analysis identified osteoarticular pain (knee and hip pain) and respiratory diseases as major factors predicting a poor HRQL in its physical dimensions, or perceived problems in everyday life. The relative importance of knee pain was higher than that of hip pain. Osteoarticular and respiratory diseases are major determinants of poor HRQL in obesity. Prevention strategies and treatment of somatic diseases are mandatory for a comprehensive approach to obesity.

Cognitive behavioural therapy (CBT) is the most comprehensive means of medically treating obesity, but only few data have so far been published concerning its long-term effectiveness. We here report our experience of 1068 consecutive patients (868 females) treated with CBT at a university-based obesity centre. The patients were enrolled into three different programmes: a 14-week LEARN programme (672 patients), a 16-week MOB programme for the morbidly obese (259 patients), or a 20-week BINGE programme for subjects affected by binge eating (137 patients). Eighty-five percent of the subjects completed the weekly programmes. The percentage of patients attending the scheduled control visits during the 1-year follow-up gradually decreased, being very low in the BINGE group (10%). The percentage weight loss was an average of 6% during the weekly courses, being higher in the MOB programme; by the end of the weekly sessions, it exceeded 10% of initial body weight in 22% of cases and increased to 36% during the follow-up. The cumulative probability of follow-up was higher among the patients undergoing the MOB and LEARN programmes than among the BINGE patients (p < 0.0001), and decreased with the increasing severity of obesity. Female gender and a weight loss of > 10% i.b.w. increased compliance to follow-up. The study further demonstrates the difficulty of achieving compliance to chronic management of obesity and the critical role of binge eating disorder in the medium-term treatment of obesity. Strategies are needed to improve adherence to a follow-up protocol.

Unlabelled: Health-related quality of life (HRQL) is poor in obese patients and not necessarily related to the severity of disease. In a large proportion of patients psychopathological distress is also present and its role on poor HRQL has never been quantified., Methods: In 207 patients entering a University-based weight-reducing programme (38 males, 169 females), a package of self-administered questionnaires was submitted to measure HRQL (Short-Form 36) and psychopathological distress [general: Symptom Check-List 90 (SCL-90); depression: Beck Depression Inventory (BDI); binge eating: Binge Eating Scale (BES)]. Several clinical and anthropometric data were also recorded., Results: HRQL, both in its physical and mental component, was significantly reduced in obesity when related to Italian population norms. SCL-90 identified psychopathological distress in 53 patients (26%), the BDI was indicative of depression in 89 cases (43%), whereas high scores of the BES were measured in 88 cases. Logistic regression analysis identified psichopathological distress as the major factor associated with poor HRQL., Conclusions: Psychiatric disturbances significantly contribute to poorly perceived health status. Only a comprehensive treatment including a specific approach to psychiatric symptoms may be effective in improving the perceived health status of obese patients seeking treatment.

Nonalcoholic fatty liver disease (NAFLD) has been associated with the insulin-resistance syndrome, at present defined as the metabolic syndrome, whose limits were recently set. We assessed the prevalence of the metabolic syndrome in 304 consecutive NAFLD patients without overt diabetes, on the basis of 3 or more criteria out of 5 defined by the U.S. National Institutes of Health (waist circumference, glucose, high-density lipoprotein [HDL]-cholesterol, triglycerides, and arterial pressure). The prevalence of the metabolic syndrome increased with increasing body mass index, from 18% in normal-weight subjects to 67% in obesity. Insulin resistance (Homeostasis Model Assessment method) was significantly associated with the metabolic syndrome (odds ratio [OR], 2.5; 95% CI, 1.5-4.2; P <.001). Liver biopsy was available in 163 cases (54%). A total of 120 patients (73.6%) were classified as having nonalcoholic steatohepatitis (NASH); 88% of them had a metabolic syndrome (vs. 53% of patients with pure fatty liver; P <.0001). Logistic regression analysis confirmed that the presence of metabolic syndrome carried a high risk of NASH among NAFLD subjects (OR, 3.2; 95% CI, 1.2-8.9; P =.026) after correction for sex, age, and body mass. In particular, the syndrome was associated with a high risk of severe fibrosis (OR, 3.5; 95% CI, 1.1-11.2; P =.032). In conclusion, the presence of multiple metabolic disorders is associated with a potentially progressive, severe liver disease. The increasing prevalence of obesity, coupled with diabetes, dyslipidemia, hypertension, and ultimately the metabolic syndrome puts a very large population at risk of forthcoming liver failure in the next decades.

Obesity is a major risk factor for several chronic diseases, but the burden associated with it also extends to psychosocial areas and to perceived health status. In 1999 an observational study on health-related quality of life in obesity was planned. The study was entirely web-based. Case Report Forms and the individual items of 7 self-administered questionnaires were directly implemented on a general database via an extranet system from 25 Italian centers. By December 2001, after enrolment had stopped, the database included anthropometric, socioeconomic and clinical data of 1944 patients (78% females). Weight-cycling was reported in over 80% of cases, overeating in 60-65%, structured physical activity in only 13-15%. Several chronic illnesses were associated. Whereas the prevalence of diabetes and hypertension was related to the degree of obesity, hyperlipidemia and coronary heart disease did not increase further with increasing obesity. A disturbed psychological mood was twice more common in females. Concern for present health was the main reason for seeking treatment in both genders; concern for body appearance was more common in females. Male subjects were more frequently assigned to dietary counseling and physical exercise, whereas in females psychotherapy was more frequently considered. Various forms of behavioral approach were planned in approximately 50% of patients. Finally, very few patients were initially considered for pharmacological intervention or bariatric surgery. The study provides a comprehensive picture of Italian patients seeking treatment for obesity. Data on perceived health status, psychological well being, body image awareness, eating behavior disorders and psychopathological distress will provide clues to a comprehensive assessment of obesity, the effects of treatments and reasons for failure.

Objective: To measure the effects of cognitive-behavioural therapy on health-related quality of life (HRQL) in obese patients, in relation to binge eating disorder., Design: Longitudinal, clinical intervention study consisting of structured sessions of cognitive-behavioural therapy, preceded by sessions chaired by a psychologist in subjects with binge eating., Subjects: Two groups of obese patients (92 treated by cognitive-behavioural therapy (77 females); 76 untreated controls (67 female), selected from the waiting list (control group)). Of 92 treated patients, 46 had a binge eating disorder at psychometric testing and structured clinical interview., Measurements: Health-related quality of life by means of Short-Form 36 questionnaire at baseline and after 3-5 months., Results: Cognitive-behavioural treatment produced an average weight loss of 9.4+/-7.5 kg, corresponding to a BMI reduction of 3.48+/-2.70 kg/m(2). No changes were observed in the control group. All scales of HRQL improved in treated subjects (by 5-19%). In obese subjects with binge eating weight loss was lower in comparison to non-bingers (7.7+/-8.1 vs 11.1+/-6.6; P=0.034). However, the improvement in HRQL was on average larger, and significantly so for Role Limitation-Physical (P=0.006), Role Limitation-Emotional (P=0.002), Vitality (P=0.003), Mental Health (P=0.032) and Social Functioning (P=0.034). Bodily Pain was the sole scale whose changes paralleled changes in body weight., Conclusions: The positive effects of cognitive-behavioural therapy, mainly in subjects with binge eating, largely outweigh the effects on body weight, resulting in a significant change in self-perceived health status.

Objective: Total serum homocysteine is a risk factor for cardiovascular disease in the general population. Further, homocysteine might be the link between psychological traits (namely anger and hostility) and cardiovascular disease, mediated by stressful events and sympathetic nervous tone., Methods: We measured total plasma homocysteine levels and psychological traits in 205 obese individuals entering a weight-reduction program (162 females; age range, 17-64 years; body mass index, 37.7 +/- 6.2 kg/m(2), mean +/- standard deviation). Psychometric assessment was performed with three self-administered questionnaires (Symptom Checklist 90, composed of nine subscales including Hostility/Anger and Depression scales; Beck Depression Inventory; and Binge Eating Scale)., Results: Homocysteine levels were moderately increased in obese individuals when compared with the normal population and higher in males (median, 12.9 micromol/L; range, 6.9-26.3) than in females (9.8; 4.6-24.6; P < 0.0002), but not different in relation to the severity of obesity. Serum folate and vitamin B12 were normal. Psychometric testing showed pathologic data in up to 50% of patients and the Anger/Hostility scale was positive in 24%, mainly female, subjects. There were no differences in psychological traits in relation to the severity of obesity. Homocysteine did not correlate with Symptom Checklist 90 values or other values of psychometric testing., Conclusions: In obese persons, psychological traits are not major determinants of total homocysteine. A different response to stressful events, not simply mediated by sympathetic nervous tone, might be present in obesity.

Aims: To investigate whether the satiety-inducing agent sibutramine affected body weight and associated anthropometry in overweight and obese (body mass index (BMI) > 27) Type 2 diabetic patients on sulphonylurea therapy., Methods: A randomized, placebo-controlled trial was undertaken in 134 patients with stable metabolic control on chronic sulphonylurea therapy. Patients were placed on moderate caloric restriction and received treatment with either sibutramine (15 mg/day) or placebo for 6 months., Results: Fifty-three of 69 sibutramine-treated and 57/65 placebo-treated patients completed the study. Both groups showed progressive weight loss. At the end of the trial weight loss was two times greater in the sibutramine group (mean +/- SEM; -4.5 +/- 0.5 kg) than placebo (-1.7 plus minus 0.5 kg, P < 0.001 vs. sibutramine). There was a trend for more patients to lose > 5% of initial body weight in the sibutramine group than placebo. BMI (P < 0.001) and waist circumference (P < 0.001) were also decreased to a greater extent by sibutramine. Mean reductions in HbA(1c) were commensurate with weight loss in both the sibutramine and placebo (- 0.78 +/- 0.17% and -0.73 +/- 0.23%; P = 0.84). Sibutramine was well tolerated with only two patients withdrawn due to potentially drug-related serious adverse events (palpitations)., Conclusions: Sibutramine, in conjunction with moderate caloric restriction, enhances weight loss and reduces waist circumference in overweight and obese Type 2 diabetic patients receiving sulphonylurea therapy. This is associated with additional improvements in glycaemic control in a limited number of patients losing > or = 10% of their baseline body weight.

Objective: To determine the influence of body mass index (BMI) on agreement between the American Diabetes Association (ADA) and the new World Health Organization diagnostic criteria for the diagnosis of diabetes mellitus and to investigate the metabolic profile of the resulting subcategories., Design: Cross-sectional study, Subjects: A total of 3018 subjects with no previous history of diabetes and fasting glucose <7.8 mmol/l, with a wide range of BMIs., Measurements: (1) Prevalence of impaired glucose regulation (IGR) and diabetes (DM) according to ADA and WHO diagnostic criteria; (2) basal and post-load insulin sensitivity and secretion, calculated on the basis of data derived from an oral glucose tolerance test (OGTT)., Results: The diagnosis according to the two classifications was concordant in 2490 subjects, discordant in 528 (452 were identified as impaired glucose tolerance (IGT) and 76 as DM only by means of OGTT). The disagreement increased with increasing BMI, being as high as 25.3% in subjects with BMI > or = 35 kg/m(2). Subjects with isolated fasting hyperglycaemia were mainly characterised by reduced insulin sensitivity and secretion in the basal state, but normal first-phase insulin secretion and moderately reduced insulin sensitivity after glucose challenge. Subjects with isolated 2 h hyperglycaemia were mainly characterised by normal basal insulin secretion and by a marked insulin resistance associated with a blunted first-phase insulin secretion after the glucose load., Conclusions: The disagreement between ADA and WHO classifications is particularly relevant in obesity, making OGTT mandatory in these subjects. Different pathogenic mechanisms are involved in isolated fasting or post-load hyperglycaemia, possibly related to a different site of insulin resistance (hepatic vs peripheral), and/or to a different disregulation of insulin secretion (basal vs post-load). A correct identification of the underlying mechanism(s) is the rationale for future studies to detect the effectiveness of different pharmacological or behavioural approaches.

Insulin sensitivity (euglycemic clamp, insulin infusion rate: 40 mU. m(-2). min(-1)) was studied in 30 subjects with biopsy-proven nonalcoholic fatty liver disease (NAFLD), normal glucose tolerance, and a BMI <30 kg/m(2). Of those 30 subjects, 9 had pure fatty liver and 21 had evidence of steatohepatitis. In addition, 10 patients with type 2 diabetes under good metabolic control and 10 healthy subjects were studied. Most NAFLD patients had central fat accumulation, increased triglycerides and uric acid, and low HDL cholesterol, irrespective of BMI. Glucose disposal during the clamp was reduced by nearly 50% in NAFLD patients, as well as in patients with normal body weight, to an extent similar to that of the type 2 diabetic patients. Basal free fatty acids were increased, whereas insulin-mediated suppression of lipolysis was less effective (-69% in NAFLD vs. -84% in control subjects; P = 0.003). Postabsorptive hepatic glucose production (HGP), measured by [6,6-(2)H(2)]glucose, was normal. In response to insulin infusion, HGP decreased by only 63% of basal in NAFLD vs. 84% in control subjects (P = 0.002). Compared with type 2 diabetic patients, NAFLD patients were characterized by lower basal HGP, but with similarly reduced insulin-mediated suppression of HGP. There was laboratory evidence of iron overload in many NAFLD patients, but clinical, histological, and biochemical data (including insulin sensitivity) were not correlated with iron status. Four subjects were heterozygous for mutation His63Asp of the HFE gene of familiar hemochromatosis. We concluded that NAFLD, in the presence of normoglycemia and normal or moderately increased body weight, is characterized by clinical and laboratory data similar to those found in diabetes and obesity. NAFLD may be considered an additional feature of the metabolic syndrome, with specific hepatic insulin resistance.

Amino acid catabolism and urea synthesis are increased in type 2 diabetes mellitus in poor metabolic control. In different catabolic conditions, prostaglandins (PGs) of the E series produced metabolic effects on nitrogen metabolism, decreasing urea formation. In 10 patients with type 2 diabetes in poor metabolic control, urea synthesis and amino acid to urea nitrogen exchange were measured in the basal state and during an alanine load (6 hours) with 2-hour superinfusion of a PGE1 analog (30 microg/h) or saline in random order. The urea synthesis rate was calculated as the sum of urinary urea excretion and urea accumulation in total body water (TBW); total nitrogen exchange was calculated as the difference between infused amino acid-nitrogen and urea appearance. Plasma alpha-aminonitrogen (alpha-amino-N) increased 100% in response to alanine, to a steady-state without differences in relation to PG superinfusion. The urea synthesis rate (mean +/- SD) was 34.0 +/- 11.4 mmol/h in the basal period and increased to 161.2 +/- 37.0 during alanine + saline and to 113.5 +/- 34.6 during alanine + PG (P < .001). Nitrogen exchange was negative at baseline (-25.0 +/- 9.0 mmol/h). It became moderately positive during alanine + saline (14.6 +/- 25.1) and far more positive during alanine + PG (53.5 +/- 21.4), with the difference due to reduced urea formation. The metabolic effects of PG were not related to differences in insulin and glucagon. We conclude that PGE1 slows the high rate of hepatic urea-N synthesis in poorly controlled type 2 diabetes. Such metabolic effects have therapeutic implications.

A poor health-related quality of life (HRQL) has been repeatedly documented in obesity. Overweight per se and associated diseases affect physical fitness, whereas mental well-being depends on social, cultural and behavioural components. Very few studies are available on HRQL in obese persons in relation to eating behaviour. We measured HRQL by means of Short-Form-36 questionnaire in 183 obese subjects, seeking specific treatment at a University-based weight management center. Only half had a Body Mass Index exceeding 35 kg/m2. Data were compared to age- and gender-adjusted normative values of the Italian population (2031 subjects). The Binge Eating Scale (BES) and the Three-Factor Eating Questionnaire (TFEQ) were used to assess eating behaviour. Most domains of HRQL were impaired in obese subjects, more severely in younger subjects and in females. The severity of overweight progressively affected physical fitness, but had a minor effect on mental status. In over 50% of subjects, BES and TFEQ identified a binge eating pattern, more frequently in females. A positive BES, as well as lower restriction, higher disinhibition and hunger values at TFEQ, identified subjects with poorer HRQL. Logistic regression analysis identified in a positive BES the variable more closely associated with low scores in mental domains of perceived HRQL. Waist-to-hip ratio, degree of obesity, osteoarticular and respiratory diseases, but also positive BES, were selected as variables more closely associated with poor physical fitness. HRQL is variably impaired in obese persons seeking treatment for their disease, mainly in patients with binge eating. Treatment of binge eating may be as important as any weight-reducing intervention for the overall well-being of the majority of obese persons.

During the last 20 years there has been much interest in nutritional treatment for patients with advanced cirrhosis. Most studies have measured the potential benefit of nutritional supplements of dietary proteins, generic protein hydrolysates, or specific branched-chain amino acid (BCAA)-enriched formulas in regard to nutritional parameters and hepatic encephalopathy. The issue is not definitively settled; data are conflicting and meta-analyses have failed to produce unequivocal results. A consensus review, recently produced under the auspices of the European Society for Parenteral and Enteral Nutrition, concluded that: (1) patients with cirrhosis tend to be hypermetabolic, and a higher-than-normal supply of dietary proteins is needed to achieve nitrogen balance; (2) most patients tolerate a normal or even increased dietary protein intake, without risk of hepatic encephalopathy; (3) a modified eating pattern, based on several meals and a late evening snack, is useful; (4) in severely malnourished patients, amino acid supplements may be considered to provide the necessary amount of proteins to meet protein requirements; (5) in a few patients intolerant to the required protein intake, BCAA supplements may be considered to provide the necessary nitrogen intake without detrimental effects on the mental state, perhaps even improving it. Future studies are needed to quantify the advantage of nutritional support with amino acids or BCAA supplements on overall well-being, complications, and ultimately survival with a long-lasting disease where self-perceived health-related quality of life is a major outcome.

Background and Purpose: Nonalcoholic fatty liver disease is frequently associated with type 2 diabetes mellitus, obesity, and dyslipidemia, but some patients have normal glucose tolerance or normal weight. We tested the hypothesis that there is an association between nonalcoholic fatty liver disease and insulin resistance that is independent of diabetes and obesity., Subjects and Methods: We measured anthropometric and metabolic variables in 46 patients with chronically elevated serum aminotransferase levels, "bright liver" on ultrasound scan, and normal glucose tolerance. Indexes of insulin resistance and secretion were determined using the homeostasis model assessment method. They were compared with 92 normal subjects who were matched for age and sex., Results: Patients with nonalcoholic fatty liver disease were characterized by fasting and glucose-induced hyperinsulinemia, insulin resistance, postload hypoglycemia, and hypertriglyceridemia. Insulin resistance [odds ratio (OR) = 15 per percent increase, 95% confidence interval (CI): 3.0 to 70], fasting triglyceride level (OR = 3.1 per mmol/liter increase, 95% CI: 1.1 to 8.9), 180-minute blood glucose level (OR = 4.3 per mmol/ liter decrease, 95% CI: 1.6 to 12), and average insulin concentration in response to oral glucose (OR = 3.0 per 100 pmol/liter increase, 95% CI: 1.5 to 6.2) were independently associated with nonalcoholic fatty liver disease. The exclusion of overweight and obese subjects did not change the results., Conclusion: Nonalcoholic fatty liver disease is associated with insulin resistance and hyperinsulinemia even in lean subjects with normal glucose tolerance. Genetic factors that reduce insulin sensitivity and increase serum triglyceride levels may be responsible for its development.

Objective: Oxygen free radicals (OFR) play a role in the pathogenesis of tissue damage in many pathological conditions via the peroxidation of membrane phospholipids. Experimental studies showed an elevated oxidative stress during hyperthyroidism, which is reduced by treatment. Therapy per se might decrease oxidative stress., Design: Fasting plasma levels of thiobarbituric acid reacting substances (TBARS), vitamin E and coenzyme Q10 were measured in 22 hyperthyroid patients, before treatment for their thyroid disease, after 13.9 [SD 9.2] weeks, when they achieved an euthyroid state on thyrostatic drugs, and again after 47.7 [21.0] weeks, off therapy. No patient presented additional risk factors for increased lipoperoxidation and/or increased OFR levels. Smokers were asked to abstain from smoking overnight., Methods: All analytes were measured by HPLC., Results: In hyperthyroidism, plasma levels of TBARS were increased, whereas vitamin E and coenzyme Q10 were reduced. Average levels of TBARS and antioxidant agents returned to normal in euthyroid patients, without differences in relation to stop of thyrostatic therapy., Conclusions: Our data confirm the presence of oxidative stress and decreased anti-oxidant metabolites in hyperthyroid patients, which are corrected in euthyroidism, without any influence of thyrostatic drugs per se. Nutritional support with antioxidant agents, which are defective during hyperthyroidism, is warranted.

Objective: Impaired glucose tolerance or diabetes are frequently observed in cirrhosis. Overt diabetes was reported to affect long term survival of cirrhotic patients by increasing the risk of hepatocellular failure, without increasing the risk of diabetes-associated cardiovascular events., Methods: We evaluated the prevalence of cardiovascular disease in 122 patients with cirrhosis, subdivided according to their glucose tolerance. The following parameters were considered: arterial pressure, peripheral vascular disease (ankle to brachial pressure ratio), ischemic heart disease, microalbuminuria, retinopathy. The prevalence of abnormal findings was compared with that observed in 60 randomly selected patients with noninsulin-dependent diabetes and in 40 controls., Results: Noninsulin-dependent diabetic patients and patients with cirrhosis and diabetes were comparable for age, metabolic control, and smoking habits; the duration of diabetes was 5 yr longer for noninsulin-dependent diabetes. In cirrhosis, the prevalence of micro- and peripheral macroangiopathy, as well as coronary heart disease, was not different in relation to glucose tolerance, it was comparable to that of controls, and significantly lower than that observed in non-insulin-dependent diabetes., Conclusions: Cirrhotic patients, even in the presence of overt diabetes, are at low risk of cardiovascular disease. The low prevalence may be related to shorter duration of diabetic disease, also in relation to reduced life expectancy, as well as to liver disease-induced abnormalities protecting the cardiovascular system from atherosclerosis.

The aim was to investigate sulodexide as a possible therapeutic tool for treating micro- and macroalbuminuria in diabetic patients. Fifteen patients (13 micro- and 2 macroalbuminuric) with Type II diabetes, were treated with 600 lipoprotein-lipase releasing units of sulodexide by the intramuscular route, daily for 28 days, and followed up for 2 months. The main evaluation parameter was the albumin excretion rate. At the end of treatment, six of the 13 microalbuminuric patients showed a decrease in the albumin excretion rate, which increased again in three of the six during follow-up. In the two macroalbuminuric patients the albumin excretion rate decreased at the end of treatment and remained unchanged after a further 2 months. Overall analysis (15 patients) showed a significant decrease (P < 0.05) in the albumin excretion rate compared with baseline. Metabolic control and blood pressure remained unchanged during the entire period of study. No adverse events were registered. It is concluded that sulodexide administration has a favourable effect in reducing the albumin excretion rate in Type II diabetic patients with micro- and macroalbuminuria.

The influence of a very-low-calorie diet (VLCD) on lipid pattern is controversial. To evaluate the long-term effect of semistarvation on lipid patterns, a group of severely obese patients [aged 37 +/- 12 y, body mass index (BMI) 40.0 +/- 0.9] underwent a VLCD for 8 wk. Total cholesterol (TC), LDL cholesterol (LDL-C), and HDL cholesterol (HDL-C), triglycerides (TGs), apolipoproteins A1 (apo A1) and B (apo B) were analyzed every week. TC (6.07 +/- 0.23 vs 5.53 +/- 0.25 mmol/L, P less than 0.0008), HDL-C (mmol/L 1.26 +/- 0.06 vs 1.04 +/- 0.05 mmol/L, P less than 0.0001), TGs (1.46 +/- 0.19 vs 1.06 +/- 0.10 mmol/L, P less than 0.0008), and apo A1 (1.57 +/- 0.06 vs 1.32 +/- 0.06 g/L, P less than 0.0002) decreased, whereas LDL-C and apo B showed a biphasic behavior: they significantly fell during the first 3 wk, but during the last weeks returned to their initial values.

In this study, we investigated the hypothesis that increased opioid activity may be involved in the development of hyperinsulinemia in women with obesity and abdominal body fat distribution. Two groups of nine obese body (body mass index [BMI], 30 to 40 kg/m2) women with abdominal (A-ob) (waist to hip ratio [WHR] greater than 0.85) or gluteo-femoral (F-ob) (WHR greater than or equal to 0.80) fat distribution were examined and compared with eight normal-weight controls. Basal beta-endorphin levels were higher in the A-ob group than in the other groups. Each woman underwent two oral glucose tolerance tests (OGTT, 75 g glucose). A bolus of naloxone (0.8 mg) followed by a constant infusion of naloxone (0.04 mg/kg/h) or saline was also administered during the glucose challenge in random order, and blood samples for glucose, insulin, and C-peptide were collected at regular times after glucose administration. No difference was observed in basal or stimulated glucose concentrations between the three groups, nor between the saline or naloxone study. However, basal and stimulated insulin levels were significantly higher in obese women (particularly in the A-ob group) than in controls. Naloxone administration, however, did not significantly modify insulin and C-peptide glucose-stimulated concentrations in controls and in the F-ob group, whereas it significantly reduced (by approximately 47%) insulin levels in the A-ob group. Partial correlation coefficients showed a significant negative correlation between percent variation of glucose-stimulated insulin incremental areas during the naloxone study and the WHR in all women considered together (r = .544, P less than .025).(ABSTRACT TRUNCATED AT 250 WORDS)

1. We investigated the effects of the chronic administration of a sympathomimetic agent on energy expenditure, protein metabolism and levels of thyroid hormones and catecholamines in 10 obese subjects after a 6-week very-low-calorie-diet programme (1965 kJ, 60 g of protein, 45 g of carbohydrates). L-(-)-Ephedrine hydrochloride (50 mg three times a day by mouth) or placebo were administered during 2-week periods (weeks 2-5 of the VLCD programme) in a randomized, double-blind, cross-over design. Five subjects began with ephedrine and five with placebo. 2. The results were analysed separately in the two groups. No difference was found between them as regards weight loss during the very-low-calorie diet and drug treatments. Conversely, ephedrine therapy induced a significantly lower daily urinary excretion of nitrogen (and, consequently, a better nitrogen balance) with respect to placebo, independently of the drug sequence. Daily urinary levels of 3-methylhistidine during ephedrine and placebo treatments were similar. The fasting resting metabolic rate (oxygen consumption, ml STP/min) fell significantly during the very-low-calorie diet in both groups, but this effect was partially and significantly prevented by administration of ephedrine. Diet therapy significantly reduced 24 h urine levels of vanillylmandelic acid and homovanillic acid, which, however, increased to pretreatment values during ephedrine treatment. No significant effects were shown on 24 h urinary concentrations of adrenaline, noradrenaline and dopamine during the very-low-calorie diet and/or ephedrine treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

To investigate the relative contribution of insulin and sex hormones in determining the abdominal pattern of fat distribution in premenopausal women, five groups of age-matched subjects were examined: Group 1 consisted of 14 normal weight eumenorrheic women (NO); Group 2 of 9 obese eumenorrheic women (OB); Group 3 of 14 normal weight hyperandrogenic women with polycystic ovary syndrome (NO-HA); Group 4 of 10 obese hyperandrogenic women with polycystic ovary syndrome (OB-HA) and, finally, Group 5 of 10 obese hyperandrogenic women with polycystic ovary syndrome and acanthosis nigricans (OB-HA-AN). Both the two normal weight groups and the three obese groups were matched for body mass index values. Sex hormone pattern showed significantly higher LH and testosterone levels in hyperandrogenic women with respect to NO and OB women but obese hyperandrogenic groups (OB-HA and OB-HA-AN) presented significantly lower LH concentrations than NO-HA. Fasting and glucose-stimulated insulin levels were significantly higher in OB than NO, in OB-HA and OB-HA-AN than in OB and NO-HA, and in OB-HA-AN than in OB-HA, without any significant difference between OB and NO-HA. Body fat distribution, expressed by the waist to hip ratio (WHR), showed progressively higher values (p less than 0.01) from NO to OB, NO-HA, OB-HA and, particularly, OB-HA-AN women. Determination coefficients r2 obtained from simple regression analysis showed that the sum of insulin values during the glucose tolerance test and testosterone levels had a more significant power in determining WHR variability.(ABSTRACT TRUNCATED AT 250 WORDS)

On 5 and 6 April 1991, at the National Research Council (CNR) in Rome, a Consensus Conference on the relationship between overweight, obesity and health was held. The conference was sponsored by FATMA (Applied Project on Disease Factors of the CNR) and UICO (Italian Society for the Study of Obesity) with the purpose of establishing guidelines for health employees. The development of the conference followed the methodology set down by OMAR to obtain a rational and significant consensus on the answers to six basic questions prepared by the planning committee. The questions were the pivotal point of the conference and were brought to the attention of all the attendees and widely diffused among the medical community; they were proposed with the aim of giving an exhaustive definition of obesity, to investigate its relationship with mortality and morbidity, to highlight its social characterization, to indicate methods of evaluation and recommendations for weight loss, to select groups at risk, and to focus general guidelines for research. After the presentation of the state of the art on 18 topics by experts in the field, the 22 members of the consensus panel, impartial experts from a vast area of the scientific community, discussed a draft document representing the answers to the questions, which was subsequently submitted to the 307 attendees, discussed and then approved. This paper is the definitive document of the Consensus Conference. The introduction explains the reasons which led to the decision to promote the conference six years after the one held in the United States. The methodology is then set out. The questions are answered in the form of recommendations and backed up by data and scientific evidence from the literature.

On April 5th and 6th 1991, at the National Research Council (CNR) in Rome, a Consensus Conference on the relationship between Overweight, Obesity and Health was held. The Conference was sponsored by FATMA (Applied Project on Disease Factors of the CNR) and UICO (Italian Society for the Study of Obesity) with the purpose of establishing guidelines for health employees. The development of the Conference followed the methodology set down by OMAR to obtain a rational and significant consensus on the answers to 6 basic questions prepared by the Planning Committee. The questions were the pivotal point of the Conference and were brought to the attention of all the attendees and widely diffused among the medical community; they were proposed with the aim of giving an exhaustive definition of obesity, to investigate its relationship with mortality and morbidity, to highlight its social characterization, to indicate methods of evaluation and recommendations for weight loss, to select groups at risk, and to focus general guidelines for research. After the presentation of the state of the art on 18 topics by experts in the field, the 22 members of the Consensus Panel, impartial experts from a vast area of the scientific community, discussed a draft document representing the answers to the questions, which was subsequently illustrated to the 307 attendees, discussed and then approved. This paper is the definitive document of the Consensus Conference. The introduction explains the reasons which led to the decision to promote the Conference six years after the one held in the United States. The methodology is then set out. The questions are answered in the form of recommendations and backed up by data and scientific demonstrations from the literature.

The aim of this study was to assess the correlation between the distribution of adipose tissue, sexual hormones and hyperinsulinemia in male obesity. Fifty-two obese males, aged 40.0 +/- 10.9 years old and with a body mass index (BMI) of 35.0 +/- 6.1 (m +/- SD), not suffering from diabetes or any other endocrine disease, were included in the study. A group of 20 subjects aged 30.5 +/- 7.9 (p less than 0.005 vs obese subjects) and with a BMI of 23.0 +/- 2.0 were used as controls. Body fat distribution was assessed using the waist/hip ratio (w/h ratio): 0.985 +/- 0.052 in obese subjects and 0.913 +/- 0.061 in controls (p less than 0.005). In comparison to control subjects, significantly lower levels of total (T) (357 +/- 132 vs 498 +/- 142 ng/dl; p less than 0.005) and free testosterone (FT) (14.2 +/- 2.9 vs 17.1 +/- 2.6 pg/ml; p less than 0.05) were found in the obese group, as well sex hormone binding globulin (SHBG) (41.7 +/- 31.9 vs 66.2 +/- 18.6 nmol/l; p less than 0.001). None of the other steroids (androstenedione, dehydroepiandrosterone-sulphate, estrone, 17 beta-estradiol, dihydrotestosterone) or FSH and LH gonadotropins assayed differed between the two groups. Significantly higher levels of insulin and C-peptide, both fasting and after a oral glucose tolerance test, were also found in obese subjects.(ABSTRACT TRUNCATED AT 250 WORDS)

To investigate the relationship between body fat distribution, sex hormones, and hyperinsulinemia in male obesity, we examined 52 obese men (body mass index [BMI], 35.0 +/- 6.1, mean +/- SD) and 20 normal-weight controls. Their waist to hip circumference ratio (WHR), which was used as an index of fat distribution, was 0.985 +/- 0.052 and 0.913 +/- 0.061 (P less than .005), respectively. Compared with controls, obese men presented significantly lower levels of total (357 +/- 132 v 498 +/- 142 ng/dL; P less than .005) and free testosterone (14.2 +/- 2.9 v 17.1 +/- 2.6 pg/mL; P less than .05) and sex hormone-binding globulin (SHBG; 41.7 +/- 31.9 v 66.2 +/- 18.6 nmol/L; P less than .001) without any significant difference on the other sex steroid or on gonadotropin concentrations. Fasting and glucose-stimulated insulin and C-peptide levels were significantly higher in obese than in controls, and in obese with the WHR value greater than 0.97 (corresponding to the distribution median) than in those with WHR lower or equal to 0.97. BMI was negatively correlated with testosterone (P less than .005), free testosterone (P less than .01), and SHBG (P less than .001) and positively with fasting (P less than .001) and glucose-stimulated (P less than .005) C-peptide concentrations, whereas no relationship was found between these variables and WHR values. On the contrary, WHR was significantly correlated with fasting and post-glucose insulin levels (P less than .05), but not with those of sex steroids.(ABSTRACT TRUNCATED AT 250 WORDS)

We evaluated the effect of a 500-ml intragastric balloon (Ballobes) on some aspects of eating-related behaviour and weight loss on nine massively obese patients. An 800-kcal mixed meal test was performed some days before, 2-3 days and 2 months after the implant of the balloon. A hypocaloric program was started after the second meal test. At hourly intervals, before and after the meal, patients were asked to rate the desire to eat, hunger, satiety and prospective consumption of food. After 2 months, weight loss was 12.0 +/- 5.1 kg. A significant decrease in the balloon diameters was observed, but none completely deflated. During the meal test performed 2-3 days after the implant, subjects rated themselves as significantly less hungry, fuller and desiring to eat less food. These patterns, however, returned to the baseline levels at the meal test performed after 2 months. No relationship was found between weight loss and reduction in the balloon diameters, nor between the latter and the changes in temporal profiles of eating ratings. The effect of a 500-ml balloon on meal-related hunger and satiety therefore seems to disappear with time.

The study of body composition is becoming increasingly important in the field of nutritional medicine. The possibility of assessing body composition easily and economically has therefore raised considerable interest. Using straightforward correlations, we have compared the data obtained from the assessment of BF% using plicometry, impedance analysis and the interactivity of close-infrared rays; in addition, we studied the possible influence of the distribution of fatty tissue, expressed as W/H, on the results obtained using these methods. One hundred and forty-eight subjects (51 M and 97 F) were studied aged between 13 and 76 years old, with BMI ranging between 16.8 and 56.4; subjects were divided into three groups according to BMI and W/H. The three methods proved to be well correlated in patients with BMI less than 30 (r between 0.92 and 0.74), whereas correlations were less marked and less significant in groups with BMI greater than 30. W/H seemed capable of influencing results obtained using these methods and this was more evident in results obtained using impedance analysis (p less than 0.0001). The three methods studied were comparable in normal weight and slightly overweight patients, whereas contrasting findings were obtained in patients with moderate and severe obesity. Extreme caution must therefore be used in interpreting the data obtained in these subjects.

The role of weight loss in the therapy of obstructive sleep apnea syndrome (OSAS) was investigated in 23 affected patients with various degrees of obesity (body mass index range 26.6-61.0) free of cranio-facial malformations. Weight loss resulted 18.5 +/- 14.7 (s.d.) kg and was significantly correlated with baseline BMI value (r = 0.94; P less than 0.0001). Weight loss significantly reduced the number of apneas + hypopneas per hour of sleep ((A + H)I) from 66.5 +/- 23.0 to 33.0 +/- 26.2 (P less than 0.0001) and improved the mean of oxygen desaturation peaks during apneas (mSaO2) from 81.9 +/- 6.9 to 87.6 +/- 3.9; P less than 0.001). A significant correlation was found between weight loss and changes in the (A + H)I (r = -0.55; P less than 0.01) and the mSaO2 (r = 0.46; P less than 0.05). The (A + H)I significantly improved in both patients who lost more than 10 kg (basal BMI: 42.3 +/- 10.0) and in those who lost less than 10 kg (basal BMI: 30.2 +/- 2.3), whereas the mSaO2 improved only in the former. Obese patients with moderate to heavy ORL pathological findings had worse pretreatment and final OSAS parameters than those with absent or mild ORL lesions. However, both groups showed a significant, although quantitatively different, improvement of the (A + H)I and mSaO2 after weight loss. Compared to those who were cured or improved after the treatment, patients who failed to obtain significant effects on OSAS clinical presentation also had a significantly higher prevalence of ORL pathology. It is concluded that: (1) weight loss improves parameters and clinical presentation of OSAS in the majority of affected obese patients; (2) a relationship exists between the entity of weight loss and that of improvement of the syndrome; (3) weight loss must be encouraged even in patients with mild to moderate overweight; (4) the presence of ORL pathology may represent a confusing factor in the interpretation of the results obtained after weight loss.

This study includes anthropometric measurements (Body Mass Index, triceps and subscapular skinfolds, % Body Fat and Mid Arm Muscle circumference) of a cross-sectional sample of 1247 elderly representative of the Italian population between 65-95 yr (522 males and 725 females). BMI at the 50th percentile is 26 for males and 27.7 for females, at the 90th it is 31.1 and 34.7 for males and females, respectively. Compared with the data of Master et al. (1960), 13% (males) and 28% (females) of the elderly Italian subjects were overweight in 1985.