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High and Low Carbohydrate Weight Loss Approaches to Type 2 Diabetes Mellitus (The Diabetes Dietary Study (DDS))
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Albert Einstein College of Medicine, General Clinical Research Center
The Bronx, New York, United States
Start Date
May 1, 2004
Primary Completion Date
December 1, 2007
Completion Date
December 1, 2008
Last Updated
July 12, 2019
105
ACTUAL participants
low-carbohydrate diet
BEHAVIORAL
low-fat diet
BEHAVIORAL
Lead Sponsor
Albert Einstein College of Medicine
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06671587