Back to resultsLifestyle Modification for Obesity-Related Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus, Overweight, Obesity
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Low carbohydrate, ketogenic diet
Low glycemic index, reduced calorie diet
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring lifestyle modification, weight loss, hyperglycemia, hypoglycemic agents
Eligibility 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
Sites / Locations
- Duke University Health System
Outcomes
Primary Outcome Measures
Hemoglobin A1c
Secondary Outcome Measures
Body weight
Serum lipoproteins
Full Information
NCT ID
NCT00415688
First Posted
December 21, 2006
Last Updated
December 21, 2006
Sponsor
Robert C. Atkins Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00415688
Brief Title
Lifestyle Modification for Obesity-Related Type 2 Diabetes
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 Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Robert C. Atkins Foundation
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Overweight, Obesity
Keywords
lifestyle modification, weight loss, hyperglycemia, hypoglycemic agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Low carbohydrate, ketogenic diet
Intervention Type
Behavioral
Intervention Name(s)
Low glycemic index, reduced calorie diet
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Secondary Outcome Measure Information:
Title
Body weight
Title
Serum lipoproteins
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C Westman, MD MHS
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lifestyle Modification for Obesity-Related Type 2 Diabetes
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