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Abstract Background A randomized control trial was performed to test whether a lifestyle intervention program, carried out in a primary healthcare setting using existing resources, can reduce the incidence of type 2 diabetes in Japanese with impaired glucose tolerance (IGT). The results of 3 years' intervention are summarized. Methods Through health checkups in communities and workplaces, 304 middle-aged IGT subjects with a mean body mass index (BMI) of 24.5 kg/m2 were recruited and randomized to the intervention group or control group. The lifestyle intervention was carried out for 3 years by public health nurses using the curriculum and educational materials provided by the study group. Results After 1 year, the intervention had significantly improved body weight (-1.5 ± 0.7 vs. -0.7 ± 2.5 kg in the control; p = 0.023) and daily non-exercise leisure time energy expenditure (25 ± 113 vs. -3 ± 98 kcal; p = 0.045). Insulin sensitivity assessed by the Matsuda index was improved by the intervention during the 3 years. The 3-year cumulative incidence tended to be lower in the intervention group (14.8% vs.8.2%, log-rank test: p = 0.097). In a sub-analysis for the subjects with a BMI > 22.5 kg/m2, a significant reduction in the cumulative incidence was found (p = 0.027). Conclusions The present lifestyle intervention program using existing healthcare resources is beneficial in preventing diabetes in Japanese with IGT. This has important implications for primary healthcare-based diabetes prevention. Trial registration number UMIN000003136

Aims/hypothesis: The independent association of depressive symptoms and diabetes distress with mortality risk in individuals with diabetes has not been evaluated. We examined the temporal joint association of diabetes distress and depressive symptoms at baseline and the subsequent risk of all-cause mortality. Methods: The longitudinal data of 3118 individuals with type 2 diabetes were obtained from a large Japanese diabetes registry. To assess the joint association of diabetes distress and depressive symptoms at baseline with the subsequent risk of all-cause mortality, the Cox proportional hazards model was used with adjustment for potential confounders. Results: The mean age, BMI and HbA1c levels were 64.7 years, 24.6 kg/m2 and 58.6 mmol/mol (7.5%), respectively, and 38.1% of the participants were women. In the multivariable-adjusted models evaluating the diabetes distress and depressive symptoms separately, the HRs for all-cause mortality were 1.67 (95% CI 1.14, 2.43; p = 0.008) and 1.40 (95% CI 1.05, 1.85; p = 0.020), respectively. In such models evaluating the joint association of diabetes distress and depressive symptoms, compared with individuals without diabetes distress or depressive symptoms (DD−/DS−), the HRs for all-cause mortality for the group without diabetes distress but with depressive symptoms (DD−/DS+), with diabetes distress but without depressive symptoms (DD+/DS−), and with diabetes distress and depressive symptoms (DD+/DS+) were 1.34 (95% CI 0.99, 1.86; p = 0.056), 1.96 (95% CI 1.10, 3.50; p = 0.023) and 1.71 (95% CI 1.06, 2.77; p = 0.029), respectively. We did not observe a significant interaction between diabetes distress and depressive symptoms with all-cause mortality risk (p = 0.2636). In the stratified analysis by sex, a significant joint association of diabetes distress and depressive symptoms with the risk of all-cause mortality was observed only in men. Conclusions/interpretation: Diabetes distress and depressive symptoms were independently associated with all-cause mortality risk in male participants with type 2 diabetes, but we did not observe a significant interaction between diabetes distress and depressive symptoms in relation to all-cause mortality. Graphical abstract [ABSTRACT FROM AUTHOR]

Abstract: Aims/Introduction: We investigated the association between four insulin regimens, and increase in glycated hemoglobin (HbA1c) and insulin dose in a real‐life clinical setting because there are no data about them among insulin regimens. Materials and Methods: Participants included 757 patients with type 2 diabetes having been treated with insulin therapy for more than 1 year. The four insulin regimens were regimen 1 (long‐acting insulin, once daily), regimen 2 (biphasic insulin, twice daily), regimen 3 (biphasic insulin, three times daily) and regimen 4 (basal–bolus therapy). Main outcomes were increases in HbA1c levels >0.5% and increases in daily insulin units after 1 year. We carried out multivariable analyses to examine differences in glycemic control and insulin dose with adjustment for possible confounders. Results: Mean HbA1c level and duration of insulin therapy were 7.8% and 11.3 years, respectively. HbA1c levels increased by >0.5% at follow up in 22.8, 24.9, 20.7, and 29.3% of participants using regimen 1, 2, 3 and 4, respectively, with no significant differences between groups. Daily insulin doses increased in 62.3, 68.8, 65.3 and 38.6% of patients, respectively (P < 0.001). Multivariable regression analysis showed that patients who received regimen 4 had significantly lower odds of requiring future insulin dose increases than those who had received regimen 2 (adjusted odds ratio 0.24, 95% confidence interval 0.14–0.41; P < 0.001). Conclusions: Many patients receiving insulin therapy showed increases in HbA1c levels and insulin doses 1 year later. The smallest increase in insulin dose was observed in the basal–bolus therapy group compared with other regimens. [ABSTRACT FROM AUTHOR]

Aims/Introduction To compare the treatment satisfaction of four classes of oral hypoglycemic agents (OHAs): dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase inhibitors (αGI), biguanides (BG) and sulfonylureas (SU), which are common initial treatments for type 2 diabetes mellitus patients in Japan, and to identify the best oral hypoglycemic agent in terms of treatment satisfaction. Materials and Methods In this 12-week, randomized, controlled, open-label study, Japanese outpatients with type 2 diabetes mellitus who were naïve to pharmacological treatment were randomly assigned a DPP-4 inhibitor, a BG., an αGI or a SU. The primary end-point was the Oral Hypoglycemic Agent Questionnaire (OHA-Q) total and subscale scores (treatment convenience, somatic symptoms and satisfaction) at week 4. Adherence, glycated hemoglobin (HbA1c) level and safety were also evaluated. Results The DPP-4 inhibitor group scored highest in the OHA-Q total and all subscale scores at week 4. The total score was significantly higher in the DPP-4 inhibitor group than in the BG or αGI groups ( P = 0.0084 and 0.0147, respectively). The mean total score at week 12 was also highest in the DPP-4 inhibitor group, with a significant difference compared with the αGI group ( P = 0.0293). The mean HbA1c decreased from baseline to week 12 in all groups. The DPP-4 inhibitor group had the highest adherence at weeks 4 and 12. A total of 11 patients reported adverse events, including one hypoglycemic event in the SU group. Conclusions The DPP-4 inhibitor was the most preferable option in terms of treatment satisfaction. [ABSTRACT FROM AUTHOR]

We assessed the prospective association between baseline levels of physical activity (PA) and the incidence of newly developed diabetic retinopathy (DR) in patients with type 2 diabetes. Data from 1,814 patients with type 2 diabetes without DR were obtained from a Japanese diabetes registry at Tenri Hospital, Nara, Japan. To assess the independent correlations between baseline PA levels and newly developed DR, the participants were divided into five categories based on their PA levels. A Cox proportional hazards model with time-varying exposure information was used and adjusted for potential confounders to assess the independent correlations. At baseline, the mean age, BMI, and hemoglobin A1c levels of the patients were 65.5 years, 24.5 kg/m2, and 7.2% (54 mmol/mol), respectively. After 2 years, newly developed DR was confirmed in 184 patients (10.1%). Patients with newly developed DR had longer duration of type 2 diabetes (14.7 versus 11.0 years, p < 0.0001), higher systolic blood pressure (139.2 versus 135.1 mmHg, p = 0.0012), lower estimated glomerular filtration rate (74.0 versus 77.1 mL/min/1.73 m2, p = 0.0382), greater urinary albumin–creatinine ratio (4.00 versus 2.45 mg/mmol, p < 0.0039), and higher HbA1c levels (7.5 versus 7.2%, p = 0.0006) than those without newly developed DR. The multivariable-adjusted hazard ratios for DR development were 0.87 (95% CI, 0.53–1.40; p = 0.557), 0.83 (95% CI, 0.52–1.31; p = 0.421), 0.58 (95% CI, 0.35–0.94; p = 0.027), and 0.63 (95% CI, 0.42–0.94; p = 0.025)for the second, third, fourth, and fifth PA categories, respectively, compared with the reference category of patients with a mean PA of 0 metabolic equivalent of task-hours/week). Higher PA levels are independently associated with a lower incidence of DR in Japanese patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]

The beta-3 adrenergic receptor ( ADRB3), primarily expressed in adipose tissue, is involved in the regulation of energy metabolism. The present study hypothesized that ADRB3 ( Trp64 Arg, rs4994) polymorphisms modulate the effects of lifestyle intervention on weight and metabolic parameters in patients with impaired glucose tolerance. Data were analyzed from 112 patients with impaired glucose tolerance in the Japan Diabetes Prevention Program, a lifestyle intervention trial, randomized to either an intensive lifestyle intervention group or usual care group. Changes in weight and metabolic parameters were measured after the 6-month intervention. The ADRB3 polymorphisms were determined using the polymerase chain reaction restriction fragment length polymorphism method. Non-carriers showed a greater weight reduction compared with the carriers in both the lifestyle intervention group and usual care group, and a greater increase of high-density lipoprotein cholesterol levels than the carriers only in the lifestyle intervention group. ADRB3 polymorphisms could influence the effects of lifestyle interventions on weight and lipid parameters in impaired glucose tolerance patients. [ABSTRACT FROM AUTHOR]

Background: A randomized control trial was performed to test whether a lifestyle intervention program, carried out in a primary healthcare setting using existing resources, can reduce the incidence of type 2 diabetes in Japanese with impaired glucose tolerance (IGT). The results of 3 years' intervention are summarized. Methods: Through health checkups in communities and workplaces, 304 middle-aged IGT subjects with a mean body mass index (BMI) of 24.5 kg/m² were recruited and randomized to the intervention group or control group. The lifestyle intervention was carried out for 3 years by public health nurses using the curriculum and educational materials provided by the study group. Results: After 1 year, the intervention had significantly improved body weight (-1.5 ± 0.7 vs. -0.7 ± 2.5 kg in the control; p = 0.023) and daily non-exercise leisure time energy expenditure (25 ± 113 vs. -3 ± 98 kcal; p = 0.045). Insulin sensitivity assessed by the Matsuda index was improved by the intervention during the 3 years. The 3-year cumulative incidence tended to be lower in the intervention group (14.8% vs.8.2%, log-rank test: p = 0.097). In a sub-analysis for the subjects with a BMI > 22.5 kg/m², a significant reduction in the cumulative incidence was found (p = 0.027). Conclusions: The present lifestyle intervention program using existing healthcare resources is beneficial in preventing diabetes in Japanese with IGT. This has important implications for primary healthcare-based diabetes prevention. Trial registration number: UMIN000003136. [ABSTRACT FROM AUTHOR]

Aims/Introduction: A method of estimating HbA1c attained after initiation of basal supported oral therapy (BOT) has not been reported previously. The aim of the present study was to determine which characteristics of patients could influence the effectiveness of BOT introduction, and to obtain an equation to estimate HbA1c after BOT initiation. Materials and Methods: Sixty consecutive insulin-naive type 2 diabetic patients with poor glycemic control (HbA1c ≥7.5%) started once-daily injections of insulin glargine. Simple correlations were calculated between parameters such as HbA1c at baseline, HbA1c at week 24, reduction rate of HbA1c over 24 weeks (calculated as: [HbA1c level at baseline - HbA1c level at week 24]/HbA1c level at baseline), duration of diabetes, and the number of classes of coadministered oral antidiabetic drugs. Using multiple linear regression models, the independent effects of these parameters on HbA1c at week 24 were evaluated separately. Results: Multiple linear regression analysis revealed that duration of diabetes (β = 0.561; P < 0.001) and HbA1c at baseline (β = 0.284; P = 0.006) were significant predictors of HbA1c at week 24. The best fitting multiple regression equation was: HbA1c at week 24 = 0.078 × duration of diabetes + 0.218 × HbA1c at baseline + 4.628 ( r2 = 0.437). Conclusions: The equation based on the multiple linear regression models indicates necessary conditions for type 2 diabetic patients to achieve target HbA1c. The present findings emphasize the principle that early initiation of BOT in type 2 diabetes effectively achieves good glycemic control. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00164.x, 2011) [ABSTRACT FROM AUTHOR]

Aims/Introduction: A method of estimating HbA1c attained after initiation of basal supported oral therapy (BOT) has not been reported previously. The aim of the present study was to determine which characteristics of patients could influence the effectiveness of BOT introduction, and to obtain an equation to estimate HbA1c after BOT initiation. Materials and Methods: Sixty consecutive insulin-naive type 2 diabetic patients with poor glycemic control (HbA1c ≥7.5%) started once-daily injections of insulin glargine. Simple correlations were calculated between parameters such as HbA1c at baseline, HbA1c at week 24, reduction rate of HbA1c over 24 weeks (calculated as: [HbA1c level at baseline - HbA1c level at week 24]/HbA1c level at baseline), duration of diabetes, and the number of classes of coadministered oral antidiabetic drugs. Using multiple linear regression models, the independent effects of these parameters on HbA1c at week 24 were evaluated separately. Results: Multiple linear regression analysis revealed that duration of diabetes (β = 0.561; P < 0.001) and HbA1c at baseline (β = 0.284; P = 0.006) were significant predictors of HbA1c at week 24. The best fitting multiple regression equation was: HbA1c at week 24 = 0.078 × duration of diabetes + 0.218 × HbA1c at baseline + 4.628 ( r2 = 0.437). Conclusions: The equation based on the multiple linear regression models indicates necessary conditions for type 2 diabetic patients to achieve target HbA1c. The present findings emphasize the principle that early initiation of BOT in type 2 diabetes effectively achieves good glycemic control. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00164.x, 2011) [ABSTRACT FROM AUTHOR]

Objectives: To determine the effects of a lifestyle intervention on the development of type 2 diabetes mellitus (T2DM) among participants with impaired glucose tolerance (IGT), in particular in the subgroup with baseline glycated hemoglobin (HbA1c) levels ≥5.7%, in primary healthcare settings., Design: Randomized controlled trial., Setting: 32 healthcare centers in Japan., Participants: Participants with IGT, aged 30-60 years, were randomly assigned to either an intensive lifestyle intervention group (ILG) or a usual care group (UCG)., Interventions: During the initial 6 months, participants in the ILG received four group sessions on healthy lifestyles by public health providers. An individual session was further conducted biannually during the 3 years. Participants in the UCG received usual care such as one group session on healthy lifestyles., Outcome Measures: The primary endpoint was the development of T2DM based on an oral glucose tolerance test., Results: The mean follow-up period was 2.3 years. The annual incidence of T2DM were 2.7 and 5.1/100 person-years of follow-up in the ILG (n=145) and UCG (n=149), respectively. The cumulative incidence of T2DM was significantly lower in the ILG than in the UCG among participants with HbA1c levels ≥5.7% (log-rank=3.52, p=0.06; Breslow=4.05, p=0.04; Tarone-Ware=3.79, p=0.05), while this was not found among participants with HbA1c levels <5.7%., Conclusions: Intensive lifestyle intervention in primary healthcare setting is effective in preventing the development of T2DM in IGT participants with HbA1c levels ≥5.7%, relative to those with HbA1c levels <5.7%., Trial Registration Number: UMIN000003136.