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Plant-Based Dietary Intervention in Type 2 Diabetes

This study has been completed.
Study NCT00276939.   Last updated on July 29, 2008.   Information provided by The Washington Center for Clinical Research

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Descriptive Information Fields
Brief Title  Plant-Based Dietary Intervention in Type 2 Diabetes
Official Title  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 Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Hemoglobin A1c [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ]
Condition  Diabetes Mellitus, Type 2
Intervention  Behavioral: Low-fat, low-Glycemic Index, vegan diet
MEDLINE PMIDs 16873779,   10446033,   16164885,   15325679,   15286527,   12936955
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  99
Start Date  September 2003
Completion Date July 2006
Eligibility 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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00276939
Organization ID PCRM GWU DM Study
Secondary IDs ††
Study Sponsor  The Washington Center for Clinical Research
Collaborators †† National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes Action Research and Education Foundation
George Washington University
University of Toronto
Investigators 
Principal Investigator:     Neal D Barnard, MD     Physicians Committee for Responsible Medicine    
Information Provided By The Washington Center for Clinical Research
Verification Date July 2008
First Received Date  January 11, 2006
Last Updated Date July 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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