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NCT00415688 Clinical Trial

Lifestyle Modification for Obesity-Related Type 2 Diabetes

Obesity Clinical Trial

Official title:
A Randomized, Controlled Trial of a Low-Carbohydrate, Ketogenic Diet Versus a Low-Glycemic Index Diet for Obesity-Related Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00415688
Other study ID # AF001
Secondary ID
Status Completed
Phase Phase 4
First received December 21, 2006
Last updated December 21, 2006
Start date July 2004
Est. completion date January 2006

Study information
Verified date December 2006
Source Robert C. Atkins Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Low carbohydrate, ketogenic diet

• Low glycemic index, reduced calorie diet

Locations
Country Name City State
United States Duke University Health System Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Robert C. Atkins Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin A1c
Secondary Body weight
Secondary Serum lipoproteins
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