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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00795691
Recruitment Status : Unknown
Verified November 2008 by Albert Einstein College of Medicine, Inc..
Recruitment status was:  Active, not recruiting
First Posted : November 21, 2008
Last Update Posted : November 21, 2008
Robert C. Atkins Foundation
Information provided by:
Albert Einstein College of Medicine, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: low-carbohydrate diet Behavioral: low-fat diet Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High and Low Carbohydrate Weight Loss Approaches to Type 2 Diabetes Mellitus AKA The Diabetes Dietary Study (DDS)
Study Start Date : May 2004
Actual Primary Completion Date : December 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
low-carbohydrate diet
Behavioral: low-carbohydrate diet
ketogenic low-carbohydrate diet in patients with type 2 diabetes

Active Comparator: 2
low-fat diet
Behavioral: low-fat diet
low-fat diet in patients with type 2 diabetes

Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 3 months, 6 months, 12 months ]
  2. Weight [ Time Frame: 3 months, 6 months, 12 months ]

Secondary Outcome Measures :
  1. body composition [ Time Frame: 6 months, 12 months ]
  2. change in antidiabetic medications [ Time Frame: 3 months, 6 months, 12 months ]
  3. insulin sensitivity [ Time Frame: 6 months, 12 months ]
  4. lipids [ Time Frame: 6 months, 12 months ]
  5. dietary intake [ Time Frame: 6 months, 12 months ]
  6. physical activity [ Time Frame: 6 months, 12 months ]
  7. Quality of life [ Time Frame: 6 months, 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00795691

United States, New York
Albert Einstein College of Medicine, General Clinical Research Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Robert C. Atkins Foundation
Principal Investigator: Judith Wylie-Rosett Albert Einstein College of Medicine, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Judith Wylie-Rosett, EdD, RD, Professor of Epidemiology and Population Health, Albert Einstein College of Medicine Identifier: NCT00795691     History of Changes
Other Study ID Numbers: 2002-180
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: November 21, 2008
Last Verified: November 2008

Keywords provided by Albert Einstein College of Medicine, Inc.:
low-carbohydrate diet
weight loss
dietary intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases