A Trial Evaluating the Effects of a One-year Lifestyle Intervention in Obese Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetic patients with uncontrolled disease are often characterized by increased energy
      expenditure and could thus present a high resting metabolic rate (RMR). Lifestyle
      interventions aimed at improving glucose control in these patients may lead to reductions of
      futile pathways, resulting in lower rates of energy expenditure, and paradoxically to making
      it more difficult to lose weight. However, only few studies investigated how exercise could
      influence patients' RMR and results are still not unanimous. In this study, we aim to
      investigate the effects on metabolic health of a combined dietary intervention and 12-week
      exercise training in obese adults with type 2 diabetes.
    

Detailed description: 
      Although a number of exercise training interventions have been proposed to type 2 diabetes
      patients, the current clinical practice demonstrates that most patients are still sedentary
      and with excess body weight. A negative balance between energy intake and energy expenditure
      is crucial to reduce excess body weight. However, diabetic patients with uncontrolled disease
      are often characterized by increased energy expenditure and could thus present a high resting
      metabolic rate (RMR). Lifestyle interventions aimed at improving glucose control in these
      patients may lead to reductions of futile pathways, resulting in lower rates of energy
      expenditure, and paradoxically to making it more difficult to lose weight. However, no robust
      evidence has been collected on this issue, and the few studies that investigated how exercise
      could influence patients' RMR have not shown unanimous results, especially concerning
      combined dietary and physical activity interventions.

      This open-label randomized trial in obese adults with type 2 diabetes aims to investigate the
      effects of a 1-year caloric restriction and 12-week exercise training intervention on
      metabolic health, RMR and VO2max.

      In particular, eligible type 2 diabetes patients of our clinic will be invited to participate
      in a short lifestyle intervention (LSI). LSI will consist of four weekly group-led lessons
      lasting 60-90 minutes in which specialized professionals will educate patients on specific
      dietary and physical activity recommendations for improving health and metabolic control.

      After this month, patients will be randomly assigned either to: 1) 1-year caloric restriction
      with an immediate start of 12-week supervised structured exercise training (SSET) (Early-SSET
      intervention), followed by no exercise at health centers for 3 months; or: 2) 1-year caloric
      restriction with no exercise at health centers for 3 months and then a 12-week SSET from
      month 4 to month 6 (Late-SSET intervention). During the last 6 months participants' activity
      will be unrestricted.

      Type 2 diabetic and obese adult volunteers will be recruited and screened through medical
      history, physical examination and biochemical analyses.
    

Intervention name(s): Caloric restriction; Exercise training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A structured dietary training will be implemented to educate participants about recommended dietary habits.Patients will follow a caloric restriction (CR) diet, with an energy intake equal to the measured Resting Metabolic Rate (RMR) and with 45% carbohydrate, 20%protein, 35%fat, and 30 g/day fibers. At each follow-up, nutritionist will adjust CR to the latest measured RMR and assess the compliance to the diet.; Trainers will supervise participants during 12-weeks of structured exercise consisting of 150 min/week workouts, divided in three sessions of progressive mixed (aerobic and resistance) exercise. All aerobic exercise will be performed using treadmill and/or cycle ergo-meter.
Other intervention name(s): One-year caloric restriction; 12-week structured supervised exercise training (SSET)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After the baseline assessment, patients will be randomly assigned either to: 1) 1-year caloric restriction with an immediate start of 12-week supervised structured exercise training (SSET) (Early-SSET intervention), followed by no exercise at health centers for 3 months; or: 2) 1-year caloric restriction with no exercise at health centers for 3 months and then a 12-week SSET from month 4 to month 6 (Late-SSET intervention). During the last 6 months participants' activity will be unrestricted.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Lifestyle intervention