Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?
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|ClinicalTrials.gov Identifier: NCT00883038|
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : April 17, 2009
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 or disease||Intervention/treatment||Phase|
|Insulin Resistance||Other: diabetic diet following the DNSG guidelines Other: low-fat vegetarian diet||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Does a Low-Fat Vegetarian Diet Improve Insulin Resistance in Individuals With Type 2 Diabetes?|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||March 2009|
Active Comparator: Active Comparator
Diabetic diet following the DNSG guidelines
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.
Low-fat vegetarian diet
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.
- Insulin resistance [ Time Frame: 6 months ]
- Visceral to subcutaneous fatty tissue ratio [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883038
|Institute for Clinical and Experimental Medicine|
|Prague, Czech Republic|
|Principal Investigator:||Terezie Pelikanova, MD, PhD||Head of the Diabetes Center|