Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments low-carbohydrate diet, low-fat diet
Sponsor Albert Einstein College of Medicine of Yeshiva University
Collaborator Robert C. Atkins Foundation
Start date May 2004
End date December 2007
Trial size 105 participants
Trial identifier NCT00795691, 2002-180

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
low-carbohydrate diet
low-carbohydrate diet
ketogenic low-carbohydrate diet in patients with type 2 diabetes
(Active Comparator)
low-fat diet
low-fat diet
low-fat diet in patients with type 2 diabetes

Primary Outcomes

Measure
Hemoglobin A1c
time frame: 3 months, 6 months, 12 months
Weight
time frame: 3 months, 6 months, 12 months

Secondary Outcomes

Measure
body composition
time frame: 6 months, 12 months
change in antidiabetic medications
time frame: 3 months, 6 months, 12 months
insulin sensitivity
time frame: 6 months, 12 months
lipids
time frame: 6 months, 12 months
dietary intake
time frame: 6 months, 12 months
physical activity
time frame: 6 months, 12 months
Quality of life
time frame: 6 months, 12 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Diagnosis of type 2 diabetes - HbA1c 7-10% - BMI (kg/m2) > 25 and < 40 and weight < 280 lb. - Skill at and willingness to perform capillary blood glucose self-monitoring ---Insulin (changed to long-acting basal during run-in) or sulfonylurea treatment Exclusion Criteria: - Age > 65 - Weight >280 lb - Health conditions that may interfere with study participation or for which the study interventions may be contraindicated. These include: kidney stones or kidney disease (creatinine > 1.3 and 1.5 mg/dL for females and males, respectively; proteinuria > 300 ug/g creatinine); liver or gall bladder disease; significant heart disease (myocardial infarction in the past six months, prior or current evidence of congestive heart failure, other evidence of LV dysfunction) or other indices of active cardiac abnormalities, (angina, electrocardiogram evidence of ischemia or transmural myocardial infarction), significant anemia; and cancer (other than effectively treated non melanomatous skin cancer and surgically treated cervical cancer in situ). - Current hypokalemia defined as serum potassium levels <3.5 mg/dL. - Osteoporosis - Type 1 diabetes (history of ketoacidosis or undetectable fasting C-peptide levels) - History of severe or repeated hypoglycemia, or hypoglycemia unawareness. Lack of recourse to another person in the immediate vicinity in the unlikely event that they require outside assistance for severe hypoglycemia. - Triglyceride levels > 400 mg/dL. - Inability or unwillingness to comply with any aspects of the dietary and research protocol. - Weight changes > 10 lbs in the past three months. - History of binge eating disorder or other eating disorders. - Pregnancy or intention to become pregnant in the next 12 months. - Current oral hypoglycemic medication that raises the blood insulin level

Additional Information

Official title High and Low Carbohydrate Weight Loss Approaches to Type 2 Diabetes Mellitus AKA The Diabetes Dietary Study (DDS)
Principal investigator Judith Wylie-Rosett
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2008.
Information provided to ClinicalTrials.gov by Albert Einstein College of Medicine of Yeshiva University.