Lifestyle Modification for Obesity-Related Type 2 Diabetes

December 21, 2006 updated by: Robert C. Atkins Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hemoglobin A1c

Secondary Outcome Measures

Outcome Measure
Body weight
Serum lipoproteins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert C. Atkins Foundation

Investigators

  • Principal Investigator: Eric C Westman, MD MHS, Duke Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

December 21, 2006

First Submitted That Met QC Criteria

December 21, 2006

First Posted (Estimate)

December 25, 2006

Study Record Updates

Last Update Posted (Estimate)

December 25, 2006

Last Update Submitted That Met QC Criteria

December 21, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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