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; for the Italian Diabetes and Exercise Study 2 (IDES_2) Investigators IMPORTANCE There is no definitive evidence that changes in physical activity/sedentary behavior can be maintained long term in individuals with type 2 diabetes. OBJECTIVE Toinvestigatewhetherabehavioralinterventionstrategycanproduceasustainedincrease in physical activity and reduction in sedentary time among individuals with type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS The Italian Diabetes and Exercise Study 2 was an open-label, assessor-blinded,randomizedclinicalsuperioritytrial,withrecruitmentfromOctober2012toFebruary 2014andfollow-upuntilFebruary2017.In3outpatientdiabetesclinicsinRome,300physicallyinactive andsedentarypatientswithtype2diabeteswererandomized1:1(stratifiedbycenter,age,anddiabetes treatment) to receive a behavioral intervention or standard care for 3 years. INTERVENTIONS All participants received usual care targeted to meet American Diabetes Association guideline recommendations. Participants in the behavioral intervention group (n = 150) received 1 individual theoretical counseling session and 8 individual biweekly theoretical and practical counseling sessions each year. Participants in the standard care group (n = 150) received only general physician recommendations. MAIN OUTCOMES AND MEASURES Co-primary end points were sustained change in physical activity volume, time spent in light-intensity and moderate-to vigorous-intensity physical activity, and sedentary time, measured by an accelerometer. RESULTS Of the 300 randomized participants (mean [SD] age, 61.6 [8.5] years; 116 women [38.7%]), 267 completed the study (133 in the behavioral intervention group and 134 in the standard care group). Median follow-up was 3.0 years. Participants in the behavioral intervention and standard care groups accumulated, respectively, 13.8 vs 10.5 metabolic equivalent-h/wk of physical activity volume (difference, 3.3 [95% CI, 2.2-4.4]; P < .001), 18.9 vs 12.5 min/d of moderate-to vigorous-intensity physical activity (difference, 6.4 [95% CI, 5.0-7.8]; P < .001), 4.6 vs 3.8 h/d of light-intensity physical activity (difference, 0.8 [95% CI, 0.5-1.1]; P < .001), and 10.9 vs 11.7 h/d of sedentary time (difference, −0.8 [95% CI, −1.0 to −0.5]; P < .001). Significant between-group differences were maintained throughout the study, but the between-group difference in moderate-to vigorous-intensity physical activity decreased during the third year from 6.5 to 3.6 min/d. There were 41 adverse events in the behavioral intervention group and 59 in the standard care group outside of the sessions; participants in the behavioral intervention group experienced 30 adverse events during the sessions (most commonly musculoskeletal injury/discomfort and mild hypoglycemia). CONCLUSIONS AND RELEVANCE Among patients with type 2 diabetes at 3 diabetes clinics in Rome who were followed up for 3 years, a behavioral intervention strategy compared with standard care resulted in a sustained increase in physical activity and decrease in sedentary time. Further rese...

Our results strongly support the hypothesis of a pivotal role of innate immunity in type-A Stanford AAD.

BackgroundWhile current recommendations on exercise type and volume have strong experimental bases, there is no clear evidence from large-sized studies indicating whether increasing training intensity provides additional benefits to subjects with type 2 diabetes.ObjectiveTo compare the effects of moderate-to-high intensity (HI) versus low-to-moderate intensity (LI) training of equal energy cost, i.e. exercise volume, on modifiable cardiovascular risk factors.DesignPre-specified sub-analysis of the Italian Diabetes and Exercise Study (IDES), a randomized multicenter prospective trial comparing a supervised exercise intervention with standard care for 12 months (2005–2006).SettingTwenty-two outpatient diabetes clinics across Italy.PatientsSedentary patients with type 2 diabetes assigned to twice-a-week supervised progressive aerobic and resistance training plus exercise counseling (n = 303).InterventionsSubjects were randomized by center to LI (n = 142, 136 completed) or HI (n = 161, 152 completed) progressive aerobic and resistance training, i.e. at 55% or 70% of predicted maximal oxygen consumption and at 60% or 80% of predicted 1-Repetition Maximum, respectively, of equal volume.Main Outcome Measure(s)Hemoglobin (Hb) A1c and other cardiovascular risk factors; 10-year coronary heart disease (CHD) risk scores.ResultsVolume of physical activity, both supervised and non-supervised, was similar in LI and HI participants. Compared with LI training, HI training produced only clinically marginal, though statistically significant, improvements in HbA1c (mean difference −0.17% [95% confidence interval −0.44,0.10], P = 0.03), triglycerides (−0.12 mmol/l [−0.34,0.10], P = 0.02) and total cholesterol (−0.24 mmol/l [−0.46, −0.01], P = 0.04), but not in other risk factors and CHD risk scores. However, intensity was not an independent predictor of reduction of any of these parameters. Adverse event rate was similar in HI and LI subjects.ConclusionsData from the large IDES cohort indicate that, in low-fitness individuals such as sedentary subjects with type 2 diabetes, increasing exercise intensity is not harmful, but does not provide additional benefits on cardiovascular risk factors.Trial Registration www.ISRCTN.org ISRCTN-04252749.

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