Lifestyle Modification for Obesity-Related Type 2 Diabetes

• Sponsor: Robert C. Atkins Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00415688
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Jul 1, 2004
• Study Completion Date: Jan 1, 2006

Outcome Measures

Primary Outcome Measures

1. Hemoglobin A1c []

Secondary Outcome Measures

1. Body weight []

2. Serum lipoproteins []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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 Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00415688
• Other Study ID Numbers: AF001
• First Posted: Dec 25, 2006
• Last Update Posted: Dec 25, 2006
• Last Verified: Dec 1, 2006

• Keywords provided by , ,: lifestyle modification; weight loss; hyperglycemia; hypoglycemic agents
• Additional relevant MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Overweight

Study Results

No Results Posted as of Dec 25, 2006