Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University Robert C. Atkins Foundation |
---|---|
Information provided by: | Albert Einstein College of Medicine of Yeshiva University |
ClinicalTrials.gov Identifier: | NCT00795691 |
The purpose of this study is to determine the effects of a low-carbohydrate diet compared to a low-fat/high-carbohydrate diet on glucose control in patients who have Type 2 Diabetes.
Condition | Intervention |
---|---|
Type 2 Diabetes |
Behavioral: low-carbohydrate diet Behavioral: low-fat diet |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | High and Low Carbohydrate Weight Loss Approaches to Type 2 Diabetes Mellitus AKA The Diabetes Dietary Study (DDS) |
Enrollment: | 105 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
low-carbohydrate diet
|
Behavioral: low-carbohydrate diet
ketogenic low-carbohydrate diet in patients with type 2 diabetes
|
2: Active Comparator
low-fat diet
|
Behavioral: low-fat diet
low-fat diet in patients with type 2 diabetes
|
Obesity is not only a risk factor for type 2 diabetes but it also frequently increases the need for insulin requirement in people with type 2 diabetes who are overweight or obese. However, since insulin is a lipogenic hormone, insulin or sulfonylurea therapy that increases circulating insulin levels often results in additional weight gain. Controlled-carbohydrate "ketogenic" diets have been popular as an alternative way of losing weight, but little is known about the safety and efficacy of using a ketogenic approach in the management of overweight/obese patients with type 2 diabetes.
The proposed study will randomize a group of 126 overweight or obese (BMI > 25 and < 40) adults with type 2 diabetes to either a low-carbohydrate or a low-fat weight loss diet. The primary study endpoint will be six and twelve month changes in glycemic control as measured by hemoglobin A1c (HbA1c). Secondary endpoints include adiposity (BMI, body composition and fat distribution); blood glucose patterns (from self-monitoring records); change in antidiabetic medications (potential decrease in number and dosage), lipids, insulin sensitivity from a meal tolerance test, other metabolic markers (C-reactive protein, leptin) and participants' lifestyle (physical activity and diet) and perceptions of satiety, quality of life, mood, and well-being.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Albert Einstein College of Medicine, General Clinical Research Center | |
Bronx, New York, United States, 10461 |
Principal Investigator: | Judith Wylie-Rosett | Albert Einstein College of Medicine of Yeshiva University |
Responsible Party: | Albert Einstein College of Medicine ( Judith Wylie-Rosett, EdD, RD, Professor of Epidemiology and Population Health ) |
Study ID Numbers: | 2002-180 |
Study First Received: | November 20, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00795691 |
Health Authority: | United States: Institutional Review Board |
diabetes low-carbohydrate diet weight loss obesity dietary intervention |
Body Weight Obesity Metabolic Diseases Weight Loss Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |