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In this study with a 2-by-2 factorial design, patients with cardiovascular risk factors and dysglycemia or type 2 diabetes received insulin glargine or standard care. Insulin treatment did not affect cardiovascular events, the primary outcome. An elevated fasting plasma glucose level is an independent risk factor for adverse cardiovascular outcomes. 1 – 7 Basal insulin secretion is required to maintain fasting plasma glucose levels below 100 mg per deciliter (5.6 mmol per liter), and an elevated fasting plasma glucose level indicates that there is insufficient endogenous insulin secretion to overcome underlying insulin resistance. 8 , 9 The correction of this deficiency may reduce cardiovascular outcomes. Such a possibility has not been formally tested; however, large outcomes trials of more versus less intense glucose lowering in which insulin was used in both study groups have not shown a clear cardiovascular . . .

Participants with impaired fasting glucose who were at risk for cardiovascular events were assigned to receive daily n−3 fatty acids or placebo and to receive insulin glargine or standard care. Supplementation with n−3 fatty acids did not reduce cardiovascular events. The use of n–3 fatty acids may have beneficial effects on arrhythmias, elevated triglyceride levels, atherosclerotic plaque, impaired endothelial function, platelet aggregation, and inflammation. Epidemiologic studies have shown a reduced risk of cardiovascular events among persons who consume fish regularly or who take supplements containing n–3 fatty acids. 1 – 4 These data have provided the impetus for clinical trials evaluating the effect of such supplements on cardiovascular events and death. These studies included participants with a variety of cardiovascular risk factors, were either open-label or placebo-controlled, and tested either dietary regimens or pharmaceutical preparations containing n–3 fatty acids. Previous meta-analyses of . . .

This study examined whether pioglitazone can reduce the risk of type 2 diabetes mellitus in adults with impaired glucose tolerance. As compared with placebo, pioglitazone reduced the conversion of IGT to diabetes by 72% but was associated with significant weight gain and edema. Type 2 diabetes mellitus affects 21 million Americans, 1 and its prevalence is increasing. 2 Microvascular and macrovascular complications are common in type 2 diabetes mellitus and are related to both the severity and the duration of hyperglycemia. 3 The natural history of type 2 diabetes mellitus has been well defined, 4 starting with a genetic predisposition and progression from normal glucose tolerance with insulin resistance to impaired glucose tolerance and eventually type 2 diabetes mellitus with the superimposition of beta-cell failure. Because hyperglycemia plays a central role in the microvascular and macrovascular complications of diabetes, 3 , 5 , 6 it is possible that interventions that . . .

The association between years of non-diabetes status after diagnosis of impaired glucose tolerance (IGT) and the risk of long-term death and cardiovascular outcomes needed to be clarified. In this post hoc analysis, we included 540 individuals with IGT who participated in the original Da Qing Diabetes Prevention Study (DQDPS). In the DQDPS, all participants were diagnosed with IGT by a 75 g oral glucose tolerance test and randomized to intervention or control groups with a 6-year lifestyle intervention trial. After the completion of the trial, death, cardiovascular events, and microvascular complications were monitored over a 30-year follow-up. In this post hoc analysis, the Cox analysis assessed the extended risk of these outcomes in individuals who either remained non-diabetes status or progressed to diabetes at the end of 2, 4, and 6 years after diagnosis of IGT. In all participants, the difference in the cumulative incidence rate of the outcomes between the diabetes and non-diabetes group gradually increased over 30 years. Compared with the diabetes group, a significantly lower risk of all-cause death (hazard ratio [HR]: 0.74; 95% confidence interval [CI]: 0.57 to 0.97, p = 0.026), cardiovascular events (HR: 0.63; 95% CI: 0.49 to 0.82, p < 0.001), and microvascular complications (HR: 0.62; 95% CI: 0.45 to 0.86, p = 0.004) first emerged in individuals who remained non-diabetes at the 4 years visit, whereas the significant risk reduction in cardiovascular death was first observed at the end of 6 years (HR: 0.56; 95% CI: 0.39 to 0.81, p = 0.002) after adjustment for age, sex, smoking status, BMI, systolic blood pressure, blood glucose, total cholesterol, intervention, and medications (including insulin plus oral hypoglycaemics, antihypertensives, and lipid-lowering agents). The results in the original intervention group alone were similar to the whole group. The main limitations of our study are the limited number of participants and the sole ethnicity of the Chinese population. In this study, we observed that maintaining several years of non-diabetes status after IGT diagnosis was associated with a significant reduction in long-term risk of death and vascular complications, and for most of these outcomes, maintaining at least 4 years of non-diabetes status may be needed to achieve a significant risk reduction.

Abstract Context The T4DM study randomized 1007 men with impaired glucose tolerance or newly diagnosed diabetes to testosterone undecanoate (TU, 1000 mg) or matching placebo (P) injections every 12 weeks for 24 months with a lifestyle program with testosterone (T) treatment reducing diabetes diagnosis by 40%. Background The long-term effects on new diagnosis of diabetes, cardiovascular and prostate disease, sleep apnea, weight maintenance trajectory and androgen dependence were not yet described. Methods A follow-up email survey after a median of 5.1 years since last injection obtained 599 (59%) completed surveys (316 T, 283 P), with participants in the follow-up survey compared with nonparticipants in 23 anthropometric and demographic variables. Results Randomization to was TU associated with stronger belief in study benefits during (64% vs 49%, P < .001) but not after the study (44% vs 40%, P = .07); there is high interest in future studies. At T4DM entry, 25% had sleep apnea with a new diagnosis more frequent on TU (3.0% vs 0.4%, P = .03) during, but not after, the study. Poststudy, resuming prescribed T treatment was more frequent among TU-treated men (6% vs 2.8%, P = .03). Five years after cessation of TU treatment there was no difference in self-reported rates of new diagnosis of diabetes, and prostate or cardiovascular disease, nor change in weight maintenance or weight loss behaviors. Conclusion We conclude that randomized T treatment for 24 months in men with impaired glucose tolerance or new diabetes but without pathological hypogonadism was associated with higher levels of self-reported benefits and diagnosis of sleep apnea during, but not after, the study as well as more frequent prescribed poststudy T treatment consistent with androgen dependence in some men receiving prolonged injectable TU.

Lifestyle intervention reduces the incidence of type 2 diabetes (T2D) in people with impaired glucose tolerance (IGT). This work aimed to find out whether participation in an earlier lifestyle intervention had an effect on the occurrence of clinically diagnosed diabetic retinopathy (DR) during a median of 22 years of follow-up time. The study included 505 individuals from the Finnish Diabetes Prevention Study (DPS) (mean age 55; range, 40-64 years at the onset of the study) with IGT who were originally randomly assigned to the intervention (weight loss, healthy diet, and physical activity) (N = 257) and usual care control groups (N = 248). The median follow-up was 22 years. Clinical retinopathy diagnoses were obtained from the Finnish national hospital Care Register for Health. Data on glycemic parameters, serum lipids, and blood pressure were available from both the intervention (median 4 years) and postintervention period (until year 7). No significant difference was found in the cumulative incidence of clinically diagnosed DR between the original intervention (N = 23, 8.9%) and control groups (N = 19, 7.7%) during the extended follow-up (odds ratio: 1.15; 95% CI, 0.61-2.21). A higher cumulative glycated hemoglobin A1c (HbA1c) was significantly associated with a higher risk of retinopathy (hazard ratio 1.4; 1.02-1.88, 95% posterior interval, adjusted for group, age, and sex). Furthermore, the incidence of retinopathy diagnosis was numerically more common among individuals who had developed diabetes during the follow-up (33/349) compared with those who had not (9/156); however, the comparison was not statistically significant (odds ratio: 1.86, 95% CI, 0.89-4.28, adjusted for group, age, and sex). A higher cumulative HbA1c was significantly associated with a higher risk of retinopathy. No evidence was found for a beneficial effect of a 4-year lifestyle intervention on the long-term occurrence of clinical DR during a median of 22-year follow-up.

OBJECTIVE: To investigate whether a pragmatic structured education program with and without pedometer use is effective for promoting physical activity and improving glucose tolerance in those with impaired glucose tolerance (IGT). RESEARCH DESIGN AND METHODS: Overweight and obese individuals with IGT were recruited from ongoing screening studies at the University Hospitals of Leicester, U.K. Participants were randomly assigned to one of three groups. Group 1 received a 3-h group-based structured education program designed to promote walking activity using personalized steps-per-day goals and pedometers. Group 2 received a 3-h group-based structured education program designed to promote walking activity using generic time-based goals. Group 3 received a brief information leaflet (control condition). Outcomes included an oral glucose tolerance test, standard anthropometric measures, ambulatory activity, and psychological variables. Follow-up was conducted at 3, 6, and 12 months. RESULTS: A total of 87 individuals (66% male, mean age 65 years) were included in this study. At 12 months, significant decreases in 2-h postchallenge glucose and fasting glucose of -1.31 mmol/l (95% CI -2.20 to -0.43) and -0.32 mmol/l (-0.59 to -0.03), respectively, were seen in the pedometer group compared with the control group. No significant improvements in glucose control were seen in those given the standard education program. CONCLUSIONS: This study suggests that a pragmatic structured education program that incorporates pedometer use is effective for improving glucose tolerance in those with IGT. This result is likely to have important implications for future primary care-based diabetes prevention initiatives.

The aim of the study was to find out whether participation in earlier intervention had an effect on the occurrence of retinopathy in study participants. We also examined risk factors (age, sex, weight, fasting and 2 h glucose, fasting insulin, blood pressure, serum lipids) for early retinal changes. The study included 522 individuals (mean 55 years old, range 40–64 years) with impaired glucose tolerance who were randomized into intervention (weight loss, healthy diet, and physical activity, N = 265) and control groups (N = 257). Intervention lasted for median of four years in 1993–2000, after which annual follow-up visits at study clinics were conducted. In the years 2002–2006 (at least five years after stopping intervention), fundus photography was offered for all study participants in four of five study clinics. Photographs were assessed by two experienced ophthalmologists (A.A. and K.K.), masked for the group assignment. After exclusion of poor quality photographs, the data of 211 individuals (N = 113 for intervention and N = 98 for control group) were included in the present study. The occurrence of microaneurysms was significantly higher in the control (37/98, 38%) than in the intervention group (27/113, 24%; p = 0.029). In the model, including age, sex, diabetes diagnosis before the retinal assessment, body mass index (BMI), and treatment group, the odds ratio for microaneurysms was markedly lower in intervention group (OR 0.52; 0.28–0.97, p = 0.039). The only risk factor that predicted the occurrence of microaneurysms was serum triglycerides at baseline (mean ± SD 1.9 ± 0.9 vs. 1.6 ± 0.7, mmol/L, with and without microaneurysms, respectively, p = 0.003). Triglycerides associated with decreased microaneurysms in regression analysis for age, sex, fasting glucose, and intervention group (OR 1.92, p = 0.018). Lifestyle intervention in overweight and obese individuals with impaired glucose tolerance showed decreased occurrence of retinal microaneurysms. Elevated serum triglycerides were associated to the development of early diabetic microangiopathy.

The increased prevalence of type 2 diabetes mellitus is a major concern for health providers. We therefore assessed whether voglibose, an α-glucosidase inhibitor, could prevent the development of type 2 diabetes in high-risk Japanese individuals with impaired glucose tolerance. 1780 eligible patients on a standard diet and taking regular exercise with impaired glucose tolerance were randomly assigned to oral voglibose 0·2 mg three times a day (n=897) or placebo (n=883) in a multicentre, double-blind, parallel group trial. Treatment was continued until participants developed type 2 diabetes (primary endpoint) or normoglycaemia (secondary endpoint), or for a minimum of 3 years, subject to the findings of an interim analysis. Analysis was by full analysis set. This trial is registered with the University Hospital Medical Information Network (UMIN) clinical trials registry, number UMIN 000001109. In the interim analysis, voglibose was better than placebo (p=0·0026) in individuals treated for an average of 48·1 weeks (SD 36·3). Patients treated with voglibose had a lower risk of progression to type 2 diabetes than did those on placebo (50 of 897 vs 106 of 881; hazard ratio 0·595, 95% CI 0·433–0·818; p=0·0014). More people in the voglibose group achieved normoglycaemia than did those in the placebo group (599 of 897 vs 454 of 881; 1·539, 1·357–1·746; p<0·0001). 810 (90%) of 897 patients in the voglibose group had adverse events versus 750 (85%) of 881 in the placebo group. Serious adverse events (all one each) in the voglibose group were cholecystitis, colonic polyp, rectal neoplasm, inguinal hernia, liver dysfunction, and subarachnoid haemorrhage, and in the placebo group were cerebral infarction and cholecystitis. Voglibose, in addition to lifestyle modification, can reduce the development of type 2 diabetes in high-risk Japanese individuals with impaired glucose tolerance. Takeda.

To elucidate the long-term cardiovascular benefit of lowering postprandial hyperglycemia (PPG) in early-stage T2DM patients. This 10-year post-trial follow-up study included 243 patients from the DIANA (DIAbetes and diffuse coronary Narrowing) study, a multi-center randomized controlled trial which compared the efficacy of one-year life-style and pharmacological (voglibose/nateglinide) intervention lowering PPG on coronary atherosclerosis in 302 early-stage T2DM subjects [impaired glucose tolerance (IGT) or newly-diagnosed T2DM] (UMIN-CTRID#0000107). MACE (all-cause death, non-fatal MI or unplanned coronary revascularization) were compared in (1) three assigned therapies (life-style intervention/vogliose/nateglinide) and (2) patients with and without improvement of PPG (reversion from IGT to NGT or from DM to IGT/NGT on 75 g oral glucose tolerance test). During the 10-year post-trial observational period, voglibose (HR = 1.07, 95%CI: 0.69–1.66, p = 0.74) or nateglinide (HR = 0.99, 95%CI: 0.64–1.55, p = 0.99) did not reduce MACE. Similarly, achieving the improvement of PPG was not associated with a reduction of MACE (HR = 0.78, 95%CI: 0.51–1.18, p = 0.25). However, in IGT subjects (n = 143), this glycemic management significantly reduced the occurrence of MACE (HR = 0.44, 95%CI: 0.23–0.86, p = 0.01), especially unplanned coronary revascularization (HR = 0.46, 95%CI: 0.22–0.94, p = 0.03). The early improvement of PPG significantly reduced MACE and unplanned coronary revascularization in IGT subjects during the post-trial 10-year period. •Pharmacological lowering PPG did not exhibit long-term cardiovascular benefit in IGT or newly-diagnosed T2DM subjects.•Similarly, achieving the improvement of PPG did not reduce the occurrence of MACE.•However, in IGT subjects, improvement of PPG was beneficial for a reduction of MACE and unplanned revascularization.