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Low Carbohydrate Diet Compared to Calorie and Fat Restricted Diet in Patients With Obesity and Type II Diabetes

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ClinicalTrials.gov Identifier: NCT00108459
Recruitment Status : Completed
First Posted : April 18, 2005
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
VA Office of Research and Development

Brief Summary:
This study is designed to address the hypothesis that in obese patients with type 2 diabetes mellitus (DM), a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over 24 months will cause 5% greater reduction in body weight in patients with obesity and type 2 DM, be safe, and will not have any detrimental effects on serum lipid concentrations.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Hyperlipidemia Behavioral: Low Carbohydrate Diet Phase 3

Detailed Description:

Objectives:

This study is designed to address the hypothesis that in obese patients with type 2 DM, a low carbohydrate diet not specifically restricted in calories compared to low fat, caloric restricted diet over a 24 months period will:

  • Primary:

    1. Cause 5% greater reduction in body weight in patients with obesity and type 2 DM;
    2. Be safe and will not have any detrimental effects on serum lipid concentrations
  • Secondary:

    1. Lead to a greater reduction in HbA1c and fasting serum glucose and insulin concentration;
    2. Lead to reduction in body fat content;
    3. Cause greater reduction in serum triglyceride concentration;
    4. Cause no significant changes in proteinuria, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), creatinine and uric acid concentrations
  • Exploratory:

Cause favorable changes in adipocytokines (serum leptin, resistin, TNF-α, TNF α- receptors, free fatty acids) and high sensitive C-reactive protein

Research Design:

This will be a single site (Philadelphia VA Medical Center); two arm, parallel, randomized, clinical trial. Obese, male, type 2 diabetic subjects (body mass index [BMI] >30 kg/m2) will be randomized in a 1:1 fashion to dietary instructions for low carbohydrate or low fat diet. Women will be randomized separately (blocks of 4) to ensure equal representation in both dietary groups. Recruitment will be done in 3 phases (for logistical reasons). Subjects will be randomized to one of the two dietary groups. One group will be instructed on a carbohydrate-restricted diet, and the other on a calorie and fat restricted diet as recommended by the National Heart, Lung and Blood Institute (NHLBI). All patients will have blood, urine, and body composition analyses measured at baseline and then at 26, 52, and 104 weeks. Dietary instructions will be given to subjects in groups of 13, and will be provided every week for the first 4 weeks and then every 4 weeks for a total of 30 visits.

Methodology: The setting is the outpatient clinics of the Philadelphia Veterans Affairs Medical Center. Inclusion criteria include: Male or female subjects > 18 years of age; Clinical diagnosis of type 2 diabetes mellitus; Body mass index of > 30 kg/m2 . Approximately 156 male and female veterans from the Philadelphia Veterans Affairs Medical Center will be enrolled in this study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Low Carbohydrate Diet in Obesity and Type 2 DM: RCT
Study Start Date : September 2004
Study Completion Date : December 2007

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U.S. FDA Resources





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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects > 18 years of age
  • Clinical diagnosis of type 2 diabetes mellitus or on insulin or oral hypoglycemic agents
  • Body mass index of > 30 kg/m2
  • The subject must we willing and able to monitor their blood glucose with a glucometer at least 2 times per week.

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 ClinicalTrials.gov identifier (NCT number): NCT00108459


Locations
United States, Pennsylvania
VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Nayyar Iqbal VA Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00108459     History of Changes
Other Study ID Numbers: ENDA-002-03F
First Posted: April 18, 2005    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: July 2007

Keywords provided by VA Office of Research and Development:
Obesity
Type 2 Diabetes
Hyperlipidemia
Insulin resistance

Additional relevant MeSH terms:
Obesity
Diabetes Mellitus, Type 2
Hyperlipidemias
Hyperlipoproteinemias
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders