Trial record 15 of 4410 for:    "Diabetes Mellitus, Type 2"

Plant-Based Dietary Intervention in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Diabetes Action Research and Education Foundation
George Washington University
University of Toronto
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT00276939
First received: January 11, 2006
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: Low-fat, low-Glycemic Index, vegan diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Plant-Based Dietary Intervention in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Physicians Committee for Responsible Medicine:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
  • Plasma lipid concentrations [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
  • Urinary albumin [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
  • Dietary Acceptability [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: September 2003
Study Completion Date: July 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276939

Locations
United States, District of Columbia
Physicians Committee for Responsible Medicine
Washington, District of Columbia, United States, 20016
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Diabetes Action Research and Education Foundation
George Washington University
University of Toronto
Investigators
Principal Investigator: Neal D Barnard, MD Physicians Committee for Responsible Medicine
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT00276939     History of Changes
Other Study ID Numbers: PCRM GWU DM Study
Study First Received: January 11, 2006
Last Updated: August 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Physicians Committee for Responsible Medicine:
Diabetes Mellitus, Type 2
Diet, Vegetarian
Diet, Fat-Restricted
Glycemic Index

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014