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Lifestyle Modification for Obesity-Related Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Robert C. Atkins Foundation
ClinicalTrials.gov Identifier:
NCT00415688
First received: December 21, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary evidence suggests that low carbohydrate diets improve glycemic control when accompanied by weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate during weight loss, we compared two weight loss diets with different carbohydrate levels for the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Overweight
Obesity
 Behavioral: Low carbohydrate, ketogenic diet
Behavioral: Low glycemic index, reduced calorie diet
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of a Low-Carbohydrate, Ketogenic Diet Versus a Low-Glycemic Index Diet for Obesity-Related Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Robert C. Atkins Foundation:

Primary Outcome Measures:
  • Hemoglobin A1c

Secondary Outcome Measures:
  • Body weight
  • Serum lipoproteins

Estimated Enrollment: 90
Study Start Date: July 2004
Estimated Study Completion Date: January 2006
  Eligibility

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

Inclusion Criteria:

  • type 2 diabetes mellitus for at least one year
  • hgba1c > 6.0
  • BMI from 27-50 kg/m2

Exclusion Criteria:

  • Unstable medical condition
  • Serious medical condition
  • AST or ALT > 100
  • Serum creatinine > 1.5
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415688

Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Robert C. Atkins Foundation
Investigators
Principal Investigator: Eric C Westman, MD MHS Duke University Health System
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00415688     History of Changes
Other Study ID Numbers: AF001
Study First Received: December 21, 2006
Last Updated: December 21, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Robert C. Atkins Foundation:
lifestyle modification
weight loss
hyperglycemia
hypoglycemic agents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013