Type 2 Diabetes Clinical Trial
Official title:
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.
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