NCT00795691

Diabetes Dietary Study- Low Carbohydrate and Low-Fat Diets in Type 2 Diabetes

High and Low Carbohydrate Weight Loss Approaches to Type 2 Diabetes Mellitus (The Diabetes Dietary Study (DDS))

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	low-carbohydrate diet	ketogenic low-carbohydrate diet in patients with type 2 diabetes
BEHAVIORAL	low-fat diet	low-fat diet in patients with type 2 diabetes

Timeline

• Start date: 2004-05-01
• Primary completion: 2007-12-01
• Completion: 2008-12-01
• First posted: 2008-11-21
• Last updated: 2019-07-12

Locations

1 site across 1 country: United States