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Sponsored by: |
Institute for Clinical and Experimental Medicine |
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Information provided by: | Institute for Clinical and Experimental Medicine |
ClinicalTrials.gov Identifier: | NCT00883038 |
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.
Condition | Intervention | Phase |
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Insulin Resistance |
Other: diabetic diet following the DNSG guidelines Other: low-fat vegetarian diet |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes? |
Enrollment: | 70 |
Study Start Date: | July 2008 |
Study Completion Date: | March 2009 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active Comparator: Active Comparator
Diabetic diet following the DNSG guidelines
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Other: diabetic diet following the DNSG guidelines
The DNSG diet consists of 15-20% protein, ≤7% saturated fat, 60-70% carbohydrate and monounsaturated fats, cholesterol ≤200 mg/day, fiber content 20-30g/day.
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Experimental: Experimental
Low-fat vegetarian diet
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Other: low-fat vegetarian diet
The low-fat vegetarian diet (~10% of energy from fat, 15% protein, and 75% carbohydrate, fiber content 40-50 g/day) consists of vegetables, fruits, grains, legumes and small amounts of nuts. Participants will be asked to avoid animal products and added fats and to favor low-glycemic index foods, such as beans and green vegetables.
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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.
Ages Eligible for Study: | 30 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
Institute for Clinical and Experimental Medicine | |
Prague, Czech Republic |
Principal Investigator: | Terezie Pelikanova, MD, PhD | Head of the Diabetes Center |
Responsible Party: | Institute for Clinical and Experimental Medicine ( Dagmar Koveslygetyova ) |
Study ID Numbers: | 785206 |
Study First Received: | July 15, 2008 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00883038 History of Changes |
Health Authority: | Czech Republic: Ethics Committee |
insulin resistance vegetarian diet |
Hyperinsulinism Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hyperinsulinism Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Insulin Resistance Glucose Metabolism Disorders |