Plant-Based Dietary Intervention in Type 2 Diabetes

August 6, 2012 updated by: Physicians Committee for Responsible Medicine
The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 22 weeks with a one-year follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. We therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

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
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Physicians Committee for Responsible Medicine

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Type 2 Diabetes Mellitus

Exclusion Criteria:

  • hemoglobin A1c values <6.5% or >10.5%
  • use of insulin for > 5 years
  • tobacco use within the preceding 6 months
  • consumption of more than 2 alcoholic beverages per day
  • current drug abuse
  • pregnancy
  • unstable medical status
  • current use of a low-fat, vegetarian diet.

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Low-fat, low-Glycemic Index, vegan diet
Behavioral: Low-fat, low-Glycemic Index, vegan diet
Active Comparator: 2
ADA diet
Behavioral: Low-fat, low-Glycemic Index, vegan diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin A1c
Time Frame: 22 weeks
22 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 22 weeks
22 weeks
Plasma lipid concentrations
Time Frame: 22 weeks
22 weeks
Urinary albumin
Time Frame: 22 weeks
22 weeks
Dietary Acceptability
Time Frame: 22 weeks
22 weeks

Collaborators and Investigators

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

Sponsor

Physicians Committee for Responsible Medicine

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Toronto
George Washington University
Diabetes Action Research and Education Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2003

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

January 11, 2006

First Submitted That Met QC Criteria

January 11, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 6, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCRM GWU DM Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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