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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Albert Einstein College of Medicine, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795691
First Posted: November 21, 2008
Last Update Posted: November 21, 2008
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.
Collaborator:
Robert C. Atkins Foundation
Information provided by:
Albert Einstein College of Medicine, Inc.
November 20, 2008
November 21, 2008
November 21, 2008
May 2004
December 2007   (Final data collection date for primary outcome measure)
  • Hemoglobin A1c [ Time Frame: 3 months, 6 months, 12 months ]
  • Weight [ Time Frame: 3 months, 6 months, 12 months ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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 AKA 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 2 Diabetes
  • 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
  • Experimental: 1
    low-carbohydrate diet
    Intervention: Behavioral: low-carbohydrate diet
  • Active Comparator: 2
    low-fat diet
    Intervention: Behavioral: low-fat diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
105
December 2008
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00795691
2002-180
Yes
Not Provided
Not Provided
Judith Wylie-Rosett, EdD, RD, Professor of Epidemiology and Population Health, Albert Einstein College of Medicine
Albert Einstein College of Medicine, Inc.
Robert C. Atkins Foundation
Principal Investigator: Judith Wylie-Rosett Albert Einstein College of Medicine, Inc.
Albert Einstein College of Medicine, Inc.
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP