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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 because the information has not been verified recently.
Verified November 2008 by Albert Einstein College of Medicine of Yeshiva University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Robert C. Atkins Foundation
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00795691
First received: November 20, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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 Intervention
Type 2 Diabetes
 Behavioral: low-carbohydrate diet
Behavioral: low-fat diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body composition [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • change in antidiabetic medications [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • insulin sensitivity [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • lipids [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • dietary intake [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • physical activity [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: May 2004
Estimated Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795691

Locations
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 of Yeshiva University
Robert C. Atkins Foundation
Investigators
Principal Investigator: Judith Wylie-Rosett Albert Einstein College of Medicine of Yeshiva University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Judith Wylie-Rosett, EdD, RD, Professor of Epidemiology and Population Health, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00795691     History of Changes
Other Study ID Numbers: 2002-180
Study First Received: November 20, 2008
Last Updated: November 20, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
diabetes
low-carbohydrate diet
weight loss
obesity
dietary intervention

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

ClinicalTrials.gov processed this record on May 23, 2013