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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00108459 |
This study is designed to address the hypothesis that in obese patients with type 2 diabetes mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body weight in patients with obesity and type 2 DM, be safe, and will not have any detrimental effects on serum lipid concentrations.
Condition | Intervention | Phase |
---|---|---|
Obesity Type 2 Diabetes Hyperlipidemia |
Behavioral: Low Carbohydrate Diet |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Low Carbohydrate Diet in Obesity and Type 2 DM: RCT |
Estimated Enrollment: | 156 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | December 2007 |
Objectives:
This study is designed to address the hypothesis that in obese patients with type 2 DM, a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over a 24 months period will:
Primary:
Secondary:
Cause favorable changes in adipocytokines (serum leptin, resistin, TNF-α, TNF α- receptors, free fatty acids) and high sensitive C-reactive protein
Research Design:
This will be a single site (Philadelphia VA Medical Center); two arm, parallel, randomized, clinical trial.
Obese, male, type 2 diabetic subjects (body mass index [BMI] >30 kg/m2) will be randomized in a 1:1 fashion to dietary instructions for low carbohydrate or low fat diet. Women will be randomized separately (blocks of 4) to ensure equal representation in both dietary groups. Recruitment will be done in 3 phases (for logistical reasons). Subjects will be randomized to one of the two dietary groups. One group will be instructed on a carbohydrate-restricted diet, and the other on a calorie and fat restricted diet as recommended by the National Heart, Lung and Blood Institute (NHLBI). All patients will have blood, urine, and body composition analyses measured at baseline and then at 26, 52, and 104 weeks. Dietary instructions will be given to subjects in groups of 13, and will be provided every week for the first 4 weeks and then every 4 weeks for a total of 30 visits.
Methodology: The setting is the outpatient clinics of the Philadelphia Veterans Affairs Medical Center. Inclusion criteria include: Male or female subjects > 18 years of age; Clinical diagnosis of type 2 diabetes mellitus; Body mass index of > 30 kg/m2 . Approximately 156 male and female veterans from the Philadelphia Veterans Affairs Medical Center will be enrolled in this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study ID Numbers: | ENDA-002-03F |
Study First Received: | April 15, 2005 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00108459 History of Changes |
Health Authority: | United States: Federal Government |
Obesity Type 2 Diabetes Hyperlipidemia Insulin resistance |
Obesity Hyperlipidemias Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Insulin Body Weight Signs and Symptoms |
Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Obesity Hyperlipidemias Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Body Weight |
Signs and Symptoms Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Glucose Metabolism Disorders Dyslipidemias Lipid Metabolism Disorders |