Search

Introduction: Poor physical performance has been shown to be a good predictor of complications in some pathologies. The objective of our study was to evaluate, in patients with colorectal neoplasia prior to surgery, physical performance and its relationship with postoperative complications and in-hospital mortality, at 1 month and at 6 months. Methods: We conducted a prospective study on patients with preoperative colorectal neoplasia, between October 2018 and July 2021. Physical performance was evaluated using the Short Physical Performance Battery (SPPB) test and hand grip strength (HGS). For a decrease in physical performance, SPPB < 10 points or HGS below the EWGSOP2 cut-off points was considered. Nutritional status was evaluated using subjective global assessment (SGA). The prevalence of postoperative complications and mortality during admission, at 1 month, and at 6 months was evaluated. Results: A total of 296 patients, mean age 60.4 ± 12.8 years, 59.3% male, were evaluated. The mean BMI was 27.6 ± 5.1 kg/m2. The mean total SPPB score was 10.57 ± 2.07 points. A total of 69 patients presented a low SPPB score (23.3%). Hand grip strength showed a mean value of 33.1 ± 8.5 kg/m2 for men and 20.7 ± 4.3 kg/m2 for women. A total of 58 patients presented low HGS (19.6%). SGA found 40.2% (119) of patients with normal nourishment, 32.4% (96) with moderate malnutrition, and 27.4% (81) with severe malnutrition. Postoperative complications were more frequent in patients with a low SPPB score (60.3% vs. 38.6%; p = 0.002) and low HGS (64.9% vs. 39.3%, p = 0.001). A low SPPB test score (OR 2.57, 95% CI 1.37–4.79, p = 0.003) and low HGS (OR 2.69, 95% CI 1.37–5.29, p = 0.004) were associated with a higher risk of postoperative complications after adjusting for tumor stage and age. Patients with a low SPPB score presented an increase in in-hospital mortality (8.7% vs. 0.9%; p = 0.021), at 1 month (8.7% vs. 1.3%; p = 0.002) and at 6 months (13.1% vs. 2.2%, p < 0.001). Patients with low HGS presented an increase in mortality at 6 months (10.5% vs. 3.3%; p = 0.022). Conclusions: The decrease in physical performance, evaluated by the SPPB test or hand grip strength, was elevated in patients with colorectal cancer prior to surgery and was related to an increase in postoperative complications and mortality.

Summary Background & aims Several studies have evaluated the effect of intragastric injection of botulinum toxin A to treat obesity, achieving mixed results. Our objective is to determine the effect of intragastric botulinum toxin A on weight loss, satiety, biomarkers, and quality of life of obese patients prior bariatric surgery. Methods Design: single-centre, randomised, double-blind, placebo-controlled clinical trial in 52 obese patients on bariatric surgery waiting lists. Two-arm parallel: the treatment group was administered intragastric botulinum toxin A by endoscopy, whereas the control group was administered physiological saline solution. Weight loss was evaluated at weeks 2, 4, 8, 16, and 24, as well as changes in body composition, satiety (Visual analogue scale (VAS) and GCSI questionnaire), quality of life (GIQLI questionnaire), and biomarkers of satiety and appetite. Results Weight loss at weeks 2, 4, 8, 16, and 24 after the endoscopy, with respect to the basal visit, was 0.6 ± 2 kg, 0.4 ± 2.7 kg, 0.4 ± 3.1 kg, 0.2 ± 4.5 kg, and 0.6 ± 4.3 kg for the control group vs 1.9 ± 2.1 kg, 2 ± 2.6 kg, 2.8 ± 4.1 kg, 3.5 ± 5.3 kg, and 4.5 ± 7 kg for the treatment group, respectively, being differences between groups significant at all times (p = 0.016, 0.031, 0.014, 0.021, and 0.023, respectively). Treatment group patients obtained a significantly higher score for GIQLI questionnaire compared with baseline (104.4 ± 13.9 points vs 97.7 ± 15.6 points; p = 0.024), showing a significant improvement in the section of subjective physical capacity. No significant differences were found regarding perception of satiety, or biomarkers of satiety and appetite. Conclusions Intragastric injection of botulinum toxin A is an effective and safe procedure to achieve a moderate weight loss and improve quality of life. Registered under clinicaltrialsregister.eu Identifier EudraCT number 2015-004391-29 https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004391-29/ES .

Summary Background There is no established insulin regimen in T2DM patients receiving parenteral nutrition. Aims To compare the effectiveness (metabolic control) and safety of two insulin regimens in patients with diabetes receiving TPN. Design Prospective, open-label, multicenter, clinical trial on adult inpatients with type 2 diabetes on a non-critical setting with indication for TPN. Patients were randomized on one of these two regimens: 100% of RI on TPN or 50% of Regular insulin added to TPN bag and 50% subcutaneous GI. Data were analyzed according to intention-to-treat principle. Results 81 patients were on RI and 80 on GI. No differences were observed in neither average total daily dose of insulin, programmed or correction, nor in capillary mean blood glucose during TPN infusion (165.3 ± 35.4 in RI vs 172.5 ± 43.6 mg/dL in GI; p = 0.25). Mean capillary glucose was significantly lower in the GI group within two days after TPN interruption (160.3 ± 45.1 in RI vs 141.7 ± 43.8 mg/dL in GI; p = 0.024). The percentage of capillary glucose above 180 mg/dL was similar in both groups. The rate of capillary glucose ≤70 mg/dL, the number of hypoglycemic episodes per 100 days of TPN, and the percentage of patients with non-severe hypoglycemia were significantly higher on GI group. No severe hypoglycemia was detected. No differences were observed in length of stay, infectious complications, or hospital mortality. Conclusion Effectiveness of both regimens was similar. GI group achieved better metabolic control after TPN interruption but non-severe hypoglycemia rate was higher in the GI group. Clinical trial registry This trial is registered at clinicaltrials.gov as NCT02706119 .

Advantages of continuous subcutaneous insulin infusion (CSII) over multiple daily injections with glargine (MDI/G) are still uncertain. We compared CSII vs. MDI/G therapy in unselected patients with type 1 diabetes using continuous glucose monitoring (CGSM). The primary end-points were glycaemic control and quality of life (QOL).A total of 45 patients with long-term diabetes and mean HbA1c values of 8.6±1.8% (70.5±15.4mmol/mol), previously treated with MDI/NPH, were switched to MDI/G for 6 months and then, unfulfilling therapy CSII indication, were randomly assigned to CSII or MDI/G for another six months. We evaluated QOL (EsDqol) and glycaemic control by measuring HbA1c levels, rate of hypoglycaemia, ketoacidosis and CGSM data.After the first phase (MDI/NPH to MDI/G) there was a significant improvement in total EsDQOL (99.72±18.38 vs. 92.07±17.65; p0.028), a 0.5% decrease in HbA1c values (8.4±1.2 vs. 7.9±0.7% [68±9.7 vs. 63±5.5mmol/mol]; p0.032), an improvement in glycaemic variability (standard deviation 66.9±14 vs. 59.4±16mg/dl; p0.05), a decrease in insulin requirements (0.87±0.29 vs. 0.80±0.25U/kg; p0.049), a decrease in number of severe hypoglycaemia episodes (0.44±0.9 vs. 0.05±0.2; p0.014), and an increase in periods of normoglycaemia measured with CGSM (15.8±10.9% vs. 23±18.4%; p0.003). Six months after randomization, significant improvements were seen in the HbA1c (7.9±0.7 vs. 7±0.6% [63±5.5 vs. 53±4.5mmol/mol]; p0.001) and EsQOL (91.66±22 vs. 84.53±1.63; p0.045) only in the CSII group. The HbA1c value was significantly lower when compared with the MDI/G group (CSII 7±0.6% [53±4.5mmol/mol] vs. MDI/G 7.6±0.9% [59.6±7.7mmol/mol]; p0.03).Intensive insulin therapy with CSII vs. MDI/G was associated with better levels of HbA1c in patients with long-term type 1 diabetes.

There are no studies that have specifically assessed the role of intravenous lipid emulsions (ILE) enriched with fish oil in people with diabetes receiving total parenteral nutrition (TPN). The objective of this study was to assess the metabolic control (glycemic and lipid) and in-hospital complications that occurred in non-critically ill inpatients with TPN and type 2 diabetes with regard to the use of fish oil emulsions compared with other ILEs. We performed a post-hoc analysis of the Insulin in Parenteral Nutrition (INSUPAR) trial that included patients who started with TPN for any cause and that would predictably continue with TPN for at least five days. The study included 161 patients who started with TPN for any cause. There were 80 patients (49.7%) on fish oil enriched ILEs and 81 patients (50.3%) on other ILEs. We found significant decreases in triglyceride levels in the fish oil group compared to the other patients. We did not find any differences in glucose metabolic control: mean capillary glucose, glycemic variability, and insulin dose, except in the number of mild hypoglycemic events that was significantly higher in the fish oil group. We did not observe any differences in other metabolic, liver or infectious complications, in-hospital length of stay or mortality., This work was supported by Instituto de Salud Carlos III (ISCIII, co-funded by Fondo Europeo de Desarrollo Regional [FEDER], European Union [EU], Una manera de hacer Europa), Ministerio de Ciencia, Innovacion y Universidades, Gobierno de Espana (PI15/01034), and Sociedad Andaluza de Endocrinologia Diabetes y Nutrition (SAEDYN) 2016 research project. Centro de Investigacion Biomedica en Red (CIBERDEM) is an initiative of the Instituto de Salud Carlos III.

Introduction Few studies assessing the relationship between oxidative stress and glycemic variability in children with type 1 diabetes mellitus (T1DM) are available, and most of them reported no significant results. Objective To assess the relationship between glucose control, glycemic variability, and oxidative stress as measured by urinary excretion of 8-iso-prostanglandin F2-alpha (8-iso-PGF2α) in children with T1DM. Materials and methods A cross-sectional study including 25 children with T1DM. Participants were evaluated during five days in two different situations: 1st phase during a summer camp, and 2nd phase in their everyday life at home. The following data were collected in each study phase:. – Six capillary blood glucose measurements per day. Mean blood glucose (MBG) levels and glucose variability parameters, including standard deviation, coefficient of variation, and mean amplitude of glycemic excursions (MAGE), were calculated. – Capillary HbA1c level. – 24-h urine sample to measure 8-iso-PGF2α. Results There were no statistically significant differences in urinary 8-iso-PGF2α levels (142 ± 37 vs. 172 ± 61 pg/mg creatinine) and glucose control and glycemic variability parameters between both phases. In the 2nd phase, statistically significant correlations were found between urinary 8-iso-PGF2α and HbA1c levels (r = 0.53), MBG (r = 0.72), standard deviation (r = 0.49), and MAGE (r = 0.42). No significant correlations between glucose control, glycemic variability and urinary 8-iso-PGF2α excretion were found in the 1st phase. Conclusions A significant correlation was found between glycemic variability and HbA1c level and urinary 8-iso-PGF2α excretion in a group of children with T1DM during their daily lives. Additional studies are needed to confirm this finding and to explore its long-term impact on health.

Background and objectives: The objective of this study was to establish reference values for hand grip strength, compare the results obtained with Collin and Jamar type dynamometers and determine their association with anthropometric and lean mass measurements. Material and methods: This cross-sectional population-based study was undertaken in Pizarra (Málaga, Spain). The grip strength of the dominant hand was measured using Collin and Jamar dynamometers. Skinfolds (triceps, abdominal, biceps of dominant arm and subscapular) were measured, and body composition was estimated. Eight hundred seventeen adults randomly selected from the census were recruited. Dynamometry reference values are presented for the dominant hand, by gender and age groups. Results: No determinations could be made with the Collin dynamometer in 69 women due to the difficulty in grasping the dynamometer. We found significant positive correlations between the measurements with Jamar and Collin dynamometers (r = 0.782; p < 0.001) and between grip strength and lean mass index (LMI), determined by both dynamometers (r = 0.538, p < 0.001 and r = 0.462, p < 0.001, respectively). Malnourished patients according to LMI had significantly lower grip strength than normally nourished patients (p < 0.001 for Jamar; p < 0.02 for Collin). Conclusions: Dynamometry reference values in the Spanish population are presented. We recommend the use of the Jamar type dynamometer versus the Collin type dynamometer. Hand grip dynamometry is associated with lean mass, which confirms its usefulness in nutritional assessment.

Few prospective cohort studies have evaluated dietary iodine intake and urinary iodine concentrations in the general adult population. We assess the evolution of urinary iodine excretion and factors that may influence it in an adult population followed for 11 years.A population-based cohort study was undertaken in Pizarra (Spain). In the three study phases (baseline (n = 886), and 6 (n = 788) and 11 years later (n = 501)), participants underwent an interview and a standardized clinical examination that included a food questionnaire, and thyroid hormone and urinary iodine determinations. Subjects with thyroid dysfunction, palpable goiter or urinary iodine excretion400 μg/L were excluded.Urinary iodine increased over the years (100.6 ± 70.0 μg/L at baseline vs. 125.4 ± 95.2 μg/L at 6 years and 141.6 ± 81.4 μg/L at 11 years; p0.0001). Urinary iodine was significantly higher in subjects who reported iodized salt consumption and in subjects with a higher intake of dairy products (p0.05). Consumption of iodized salt (Risk ratio (RR) = 1.23, 95% CI [1.01-2.05]) and dairy products (RR = 2.07, 95% CI [1.01-4.23]), and a baseline urinary iodine concentration ≥100 μg/L (RR = 1.26, 95% CI [1.04-1.53]) were significantly associated with urinary iodine concentrations ≥100 μg/L at 11 years. There is no correlation between thyroid function (TSH, free triiodothyronine or free thyroxine levels) and urinary iodine concentrations in conditions of iodine sufficiency.The increase in urinary iodine concentrations over eleven years is associated with an increase in iodized salt intake and with the dairy products intake, and possibly with a higher iodine content of dairy products. However, individual variability in urinary iodine excretion was not fully explained by dietary iodine intake alone; previous urinary iodine concentrations were also important.

OBJECTIVE Hyperglycemia may increase mortality in patients who receive total parenteral nutrition (TPN). However, this has not been well studied in noncritically ill patients (i.e., patients in the nonintensive care unit setting). The aim of this study was to determine whether mean blood glucose level during TPN infusion is associated with increased mortality in noncritically ill hospitalized patients. RESEARCH DESIGN AND METHODS This prospective multicenter study involved 19 Spanish hospitals. Noncritically ill patients who were prescribed TPN were included prospectively, and data were collected on demographic, clinical, and laboratory variables as well as on in-hospital mortality. RESULTS The study included 605 patients (mean age 63.2 ± 15.7 years). The daily mean TPN values were 1.630 ± 323 kcal, 3.2 ± 0.7 g carbohydrates/kg, 1.26 ± 0.3 g amino acids/kg, and 0.9 ± 0.2 g lipids/kg. Multiple logistic regression analysis showed that the patients who had mean blood glucose levels >180 mg/dL during the TPN infusion had a risk of mortality that was 5.6 times greater than those with mean blood glucose levels CONCLUSIONS Hyperglycemia (mean blood glucose level >180 mg/dL) in noncritically ill patients who receive TPN is associated with a higher risk of in-hospital mortality.

SummaryObjective Modifications in lifestyle, diet and certain clinical events are major contributors for the high prevalence of obesity. The aim of this study was to assess factors associated with weight gain in a population of Spanish adults. Design The study was undertaken in two population-based cohorts from the north and the south of Spain (baseline and after 6 years). The Asturias Study, in the north, included 1034 persons aged 30–75 years, of whom 701 were reassessed. The Pizarra Study, in the south, included 1226 persons aged 18–65 years, of whom 783 were re-evaluated. Both studies involved a nutritional questionnaire, a physical examination and an oral glucose tolerance test (OGTT). Results During the follow-up, 32·3% of the participants lost weight, 34·5% gained fewer than 4 kg and 33·2% gained more than 4 kg. Weight gain was greater in persons younger than 50 years and in those with an initial body mass index below 30. Weight gain was associated with a greater incidence of type 2 diabetes mellitus (T2DM) and abnormal glucose tolerance, whereas weight loss in persons with these disorders was associated with a normal OGTT 6 years later. Persons who took less exercise and those who reported a higher daily calorie intake experienced greater weight gain. Conclusion The longitudinal changes in weight affect the development of T2DM and abnormal glucose tolerance. The weight is a dynamic phenomenon affected by several social customs.

Hypoglycemia is the most common adverse event associated with insulin treatment in diabetes. The consequences of hypoglycemia can be quite aversive and potentially life threatening. The physical sequelae provide ample reason for patients to fear hypoglycemia and avoid episodes. For these reasons, our purpose in this study was to develop a new measure that explores specific fear of hypoglycemia (FH) in adult patients with type 1 diabetes and to examine its psychometric properties. The instrument developed to assess FH was initially made up of 20 items, of which 18 were negative and 2 were positive, assessed on a 5-point Likert scale (1-5). This scale was completed by 229 patients with type 1 diabetes. Additionally, a structured interview and a closed question called subjective fear of hypoglycemia were included as diagnostic criteria. A factor analysis employing the principal-components method and promax rotation was carried out, resulting in a new scale composed of 15 items. Three factors (fear, avoidance, and interference) were obtained and explained 58.27% of the variance. The scale showed good internal consistency (Cronbach's α = .891) and test-retest reliability (r = .908, p < .001), as well as adequate concurrent and predictive validity. The cutoff score that provided the highest overall sensitivity and specificity was set at 28 points. The Fear of Hypoglycemia 15-item scale (FH-15) demonstrated good reliability and validity. This study suggests that the new instrument may serve as a valuable measure of specific FH for use in research and clinical practice.

Objective The aim of this study was to undertake a prospective study of the changes in certain risk factors for cardiovascular disease occurring during menopause. Methods A longitudinal cohort study of 475 women was followed up for 6 years (Pizarra Study). The final menstrual period was defined after at least 6 months of amenorrhea. The women were classified into three groups: group 1, no menopause at either the first or second study; group 2, no menopause at the first study but menopause at the second study (6 y later); and group 3, menopause at the first study (and also at the second). The following are the main outcome measures used: age; body mass index; waist circumference; waist-to-hip ratio; skinfold thickness; arm circumference; intake of macronutrients (quantitative questionnaire); systolic and diastolic blood pressures; cholesterol, triglycerides; high-density lipoprotein cholesterol; uric acid; homeostasis model assessment of insulin resistance; and the prevalence of obesity, hypertension, type 2 diabetes mellitus, impaired glucose tolerance, and impaired fasting glucose. Results None of the cardiovascular risk factors studied changed during the passage from premenopause to postmenopause, independently of age or physical activity. Conclusions Menopause is a biological condition of the human species, for which has recently received attempts at medicalization that were not always justified. If menopause is not accompanied by any other cardiovascular risk factor independently of age, the stigma of menopause being considered a risk factor should cease. Although the results have the strength of a prospective study, the sample size forced us to consider these findings as preliminary.

Hypoglycemia is a common problem among hospitalized patients. Treatment of hyperglycemia with insulin is potentially associated with an increased risk for hypoglycemia. The aim of this study was to determine the prevalence and predictors of hypoglycemia (capillary blood glucose70 mg/dL) in hospitalized patients receiving total parenteral nutrition (TPN).This prospective multicenter study involved 19 Spanish hospitals. Noncritically ill adults who were prescribed TPN were included, thus enabling us to collect data on capillary blood glucose and insulin dosage.The study included 605 patients of whom 6.8% (n = 41) had at least one capillary blood glucose70 mg/dL and 2.6% (n = 16) had symptomatic hypoglycemia. The total number of hypoglycemic episodes per 100 d of TPN was 0.82. In univariate analysis, hypoglycemia was significantly associated with the presence of diabetes, a lower body mass index (BMI), and treatment with intravenous (IV) insulin. Patients with hypoglycemia also had a significantly longer hospital length of stay, PN duration, higher blood glucose variability, and a higher insulin dose. Multiple logistic regression analysis showed that a lower BMI, high blood glucose variability, and TPN duration were risk factors for hypoglycemia. Use of IV insulin and blood glucose variability were predictors of symptomatic hypoglycemia.The occurrence of hypoglycemia in noncritically ill patients receiving PN is low. A lower BMI and a greater blood glucose variability and TPN duration are factors associated with the risk for hypoglycemia. IV insulin and glucose variability were predictors of symptomatic hypoglycemia.

Hypoglycemia is one of the main burdens for type I Diabetes Mellitus (DM I) patients. The consequences of hypoglycemia can be quite unpleasant due to the variety of disagreeable physical and psychological symptoms it triggers. The patient's previous experience with hypoglycemia episodes will condition his psychological reaction to future episodes, promoting behavioral modifications that associate with poor glycemic control and worse prognosis, and even with developing psychological disorders, leading to fear of hypoglycemia (FH). To be able to provide tailored prevention and treatment of patients with FH it is necessary to identify the risk factors in DM I patients. We developed and validated the FH-15 scale, a novel instrument to assess FH, which showed good concurrent and predictive validity in DM I patients. In this work we aim to identify the risk factors for suffering FH by detecting DM I patients with FH using the FH-15 scale and then analyzing the association of clinical and sociodemographic variables. We found that age, needing help to resolve an episode of hypoglycemia, and a perceived lack of social support are risk factors for suffering FH.

The aim of this study was to validate the ability of the Finnish Diabetes Risk Score (FINDRISC) to predict the risk of DM2 in a population of south-eastern Spain (Pizarra Study).The Pizarra Study is a population-based prospective study developed in the town of Pizarra (Málaga). The first phase of the study was conducted in 1997-1998, including 1051 individuals aged 18-65 years randomly selected from the municipal census of the town. In 2003-2004 the subjects participating in the first study were reassessed. 824 individuals completed the second phase of the study (78.4%). All participants without known diabetes underwent an oral glucose tolerance test both at baseline and follow-up. We evaluated the ability of the FINDRISC to detect undiagnosed DM2 (first phase: cross-sectional study) and in predicting the incidence of DM2 (second phase: cohort study).The test showed good results both to detect undiagnosed DM2 (ROC-AUC 0.74) and to predict incident DM2 (ROC-AUC 0.75). The best prediction of risk of incident DM2 was found in those subjects with fasting glucose100mg/dl and a FINDRISC ≥9 (OR: 19.37; 95%IC: 8,86-42,34; P.0001).The results of our study show that FINDRISC can be a useful tool to detect subjects at high risk of diabetes in this population.