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Plant-Based Dietary Intervention in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00276939
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : August 7, 2012
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes Action Research and Education Foundation
George Washington University
University of Toronto
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine

Tracking Information
First Submitted Date  ICMJE January 11, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date August 7, 2012
Study Start Date  ICMJE September 2003
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2008)
Hemoglobin A1c [ Time Frame: 22 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
Hemoglobin A1c
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2008)
  • Body weight [ Time Frame: 22 weeks ]
  • Plasma lipid concentrations [ Time Frame: 22 weeks ]
  • Urinary albumin [ Time Frame: 22 weeks ]
  • Dietary Acceptability [ Time Frame: 22 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
  • Body weight
  • Plasma lipid concentrations
  • Urinary albumin
  • Dietary Acceptability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Plant-Based Dietary Intervention in Type 2 Diabetes
Official Title  ICMJE Plant-Based Dietary Intervention in Type 2 Diabetes
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Behavioral: Low-fat, low-Glycemic Index, vegan diet
Study Arms  ICMJE
  • Experimental: 1
    Low-fat, low-Glycemic Index, vegan diet
    Intervention: Behavioral: Low-fat, low-Glycemic Index, vegan diet
  • Active Comparator: 2
    ADA diet
    Intervention: Behavioral: Low-fat, low-Glycemic Index, vegan diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2006)
99
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276939
Other Study ID Numbers  ICMJE PCRM GWU DM Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Physicians Committee for Responsible Medicine
Study Sponsor  ICMJE Physicians Committee for Responsible Medicine
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Diabetes Action Research and Education Foundation
  • George Washington University
  • University of Toronto
Investigators  ICMJE
Principal Investigator: Neal D Barnard, MD Physicians Committee for Responsible Medicine
PRS Account Physicians Committee for Responsible Medicine
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP