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OBJECTIVE To examine the effect of supervised exercise on traditional and nontraditional cardiovascular risk factors in sedentary, overweight/obese insulin-treated subjects with type 2 diabetes from the Italian Diabetes Exercise Study (IDES). RESEARCH DESIGN AND METHODS The study randomized 73 insulin-treated patients to twice weekly supervised aerobic and resistance training plus structured exercise counseling (EXE) or to counseling alone (CON) for 12 months. Clinical and laboratory parameters were assessed at baseline and at the end of the study. RESULTS The volume of physical activity was significantly higher in the EXE versus the CON group. Values for hemoglobin A1c, BMI, waist circumference, high-sensitivity C-reactive protein, blood pressure, LDL cholesterol, and the coronary heart disease risk score were significantly reduced only in the EXE group. No major adverse events were observed. CONCLUSIONS In insulin-treated subjects with type 2 diabetes, supervised exercise is safe and effective in improving glycemic control and markers of adiposity and inflammation, thus counterbalancing the adverse effects of insulin on these parameters.

A positive impact of exercise intervention programmes on quality of life (QoL) may be important for long-term patient compliance to exercise recommendations. We have previously shown that QoL improves significantly with supervised exercise, whereas it worsens with counselling alone, in patients with type 2 diabetes from the Italian Diabetes and Exercise Study (IDES). Here, we report data on the relationship between changes in QoL and volume of physical activity/exercise in these individuals. This multicentre parallel randomised controlled, open-label, trial enrolled sedentary patients with type 2 diabetes (n = 606 of 691 eligible) in 22 outpatient diabetes clinics. Patients were randomised by centre, age and diabetes treatment using a permuted-block design to twice-a-week supervised aerobic and resistance training plus exercise counselling (exercise group) versus counselling alone (control group) for 12 months. Health-related QoL was assessed by the 36-Item Short Form (SF-36) Health Survey. In the exercise group (n = 268 of 303 randomised), there was a trend for increasing QoL with increasing exercise volume, with significant improvement of the physical component summary (PCS) measure only above 17.5 metabolic equivalents h−1 week−1 and a clear volume-relationship for the mental component summary (MCS) measure. A relationship with volume of physical activity also was observed in the control group (n = 260 of 303 randomised), despite overall deterioration of all scores. Independent correlates of improvements in both PCS and MCS were exercise volume, study arm and, inversely, baseline score. This large trial shows a relationship between changes in physical and mental health-related QoL measures and volume of physical activity/exercise, with supervised exercise training also providing volume-independent benefits. ISRCTN-04252749 The study was funded by Lifescan SrL, Novo Nordisk Ltd, Bristol Myers Squibb Italy, Technogym SpA and Cosmed SrL.

OBJECTIVE Physical fitness is inversely related to mortality in the general population and in subjects with type 2 diabetes. Here, we present data concerning the relationship between changes in physical fitness and modifiable cardiovascular risk factors in subjects with type 2 diabetes from the Italian Diabetes and Exercise Study. RESEARCH DESIGN AND METHODS Sedentary patients with type 2 diabetes (n = 606) were enrolled in 22 outpatient diabetes clinics and randomized to twice-a-week supervised aerobic and resistance training plus exercise counseling versus counseling alone for 12 months. Baseline to end-of-study changes in cardiorespiratory fitness, strength, and flexibility, as assessed by Vo2max estimation, a 5–8 maximal repetition test, and a hip/trunk flexibility test, respectively, were calculated in the whole cohort, and multiple regression analyses were applied to assess the relationship with cardiovascular risk factors. RESULTS Changes in Vo2max, upper and lower body strength, and flexibility were significantly associated with the variation in the volume of physical activity, HbA1c, BMI, waist circumference, high-sensitivity C-reactive protein (hs-CRP), coronary heart disease (CHD) risk score, and inversely, HDL cholesterol. Changes in fitness predicted improvements in HbA1c, waist circumference, HDL cholesterol, hs-CRP, and CHD risk score, independent of study arm, BMI, and in case of strength, also waist circumference. CONCLUSIONS Physical activity/exercise-induced increases in fitness, particularly muscular, predict improvements in cardiovascular risk factors in subjects with type 2 diabetes independently of weight loss, thus indicating the need for targeting fitness in these individuals, particularly in subjects who struggle to lose weight.

In the recent Italian Diabetes and Exercise Study (IDES),1 we showed that a strategy combining a prescribed and supervised mixed training program with structured exercise counseling is more effective than counseling alone in improving physical fitness, hemoglobin A1c level and other modifiable cardiovascular risk factors, and coronary heart disease 10-year risk scores in a large cohort of sedentary subjects with type 2 diabetes mellitus. In addition, subjects participating in the supervised sessions performed a higher volume of physical activity (PA) compared with the control group. However, long-term patient compliance with exercise recommendations is largely dependent on changes in quality of life (QoL) associated with training. Unfortunately, although increased PA is expected to improve QoL and most epidemiological studies have demonstrated an association between exercise and QoL in the general population, the very few intervention trials investigating the impact of structured exercise counseling or supervised training on physical and mental health and well-being in diabetic subjects have provided inconclusive results. We report herein data on the effect of supervised mixed exercise training on top of structured exercise counseling compared with counseling alone on QoL-related measures in subjects with type 2 diabetes participating in the IDES.

Cardiorespiratory fitness is inversely related to the development of type 2 diabetes and cardiovascular morbidity and mortality. Trials in individuals with impaired glucose tolerance have highlighted the role of physical activity/exercise in the prevention of type 2 diabetes. Moreover, physical activity and exercise training have been recognized as treatment options for patients with type 2 diabetes. Both aerobic and resistance training were shown to produce beneficial effects by reducing HbA(1c), inducing weight loss and improving fat distribution, lipid profile and blood pressure in patients with type 2 diabetes. Mixed aerobic and resistance training was recently shown to be more effective than either one alone in ameliorating HbA(1c). However, further research is needed to establish the volume, intensity and type of exercise that are required to reduce cardiovascular burden and particularly to define the best strategy for promoting long-term compliance and durable lifestyle changes in individuals with type 2 diabetes. The Italian Diabetes Exercise Study (IDES) is a prospective Italian multicentre randomized controlled trial, of larger size and longer duration than previously published trials. It has been designed to assess the combined effect of structured counselling and supervised mixed (aerobic plus resistance) exercise training, as compared with counselling alone, on HbA(1c) and other cardiovascular risk factors as well as fitness parameters in individuals with type 2 diabetes and the metabolic syndrome. This study was also aimed at testing a sustainable strategy for promoting and maintaining a sufficient level of physical activity among individuals with type 2 diabetes to be implemented at the population level.

Background While 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. Objective To 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. Design Pre-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). Setting Twenty-two outpatient diabetes clinics across Italy. Patients Sedentary patients with type 2 diabetes assigned to twice-a-week supervised progressive aerobic and resistance training plus exercise counseling (n = 303). Interventions Subjects 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) A(1c) and other cardiovascular risk factors; 10-year coronary heart disease (CHD) risk scores. Results Volume 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 HbA(1c) (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. Conclusions Data 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.