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

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108459
First received: April 15, 2005
Last updated: January 20, 2009
Last verified: July 2007
  Purpose

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 Intervention Phase
Obesity
Type 2 Diabetes
Hyperlipidemia
Behavioral: Low Carbohydrate Diet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Low Carbohydrate Diet in Obesity and Type 2 DM: RCT

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 156
Study Start Date: September 2004
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108459

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

No publications provided by Department of Veterans Affairs

Additional 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
Study First Received: April 15, 2005
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Obesity
Type 2 Diabetes
Hyperlipidemia
Insulin resistance

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

ClinicalTrials.gov processed this record on July 22, 2014