Insulin Resistance Clinical Trial
Official title:
Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
The aim of the study is to evaluate the effect of experimental (vegetarian) diet compared to
conventional diet with similar caloric restriction on insulin resistance, body weight and
body composition in type 2 diabetic patients after 3 month diet program and additional 3
month diet program combined with intensive exercise.
Hypothesis: Greater improvement in insulin resistance, greater weight loss without
compromising the body composition (subjects will lose fat preferentially to lean body mass)
and differences in the fatty tissue metabolism will be found in the experimental
(vegetarian) group compared to the control (conventional diet) group despite the similar
advise on caloric restriction in both diets. The differences between the two groups will
increase after an intensive physical exercise program.
Open randomized study. Individuals with type 2 diabetes (n=60) will be recruited through newspaper advertisements and through advertisements in the hospital. They will be randomly assigned to a low-fat vegetarian diet or a diet following the guidelines of the Study Group on Diabetes and Nutrition of the European Association for the Study of Diabetes (DNSG) (21) with similar caloric restriction (-500 kcal/d). The participants will be followed for 12 weeks and then for another 12 weeks with the addition of intensive physical exercise. All meals during the 6 months will be provided. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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