Lifestyle Modification for Obesity-Related Type 2 Diabetes

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Overweight; Obesity

• Registration Number: NCT00415688
• Lead Sponsor: Robert C. Atkins Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study Completion: 2006-01
• Status Verified: 2006-12
• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Last Update Submitted: 2006-12-21
• Study First Posted: 2006-12-25
• Last Update Posted: 2006-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c

Secondary Outcome Measures

Name	Time	Method
Body weight
Serum lipoproteins

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States