Plant-Based Dietary Intervention in Type 2 Diabetes

NCT ID: NCT00276939

Last Updated: 2012-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Keywords

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Diabetes Mellitus, Type 2 Diet, Vegetarian Diet, Fat-Restricted Glycemic Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Low-fat, low-Glycemic Index, vegan diet

Group Type EXPERIMENTAL

Low-fat, low-Glycemic Index, vegan diet

Intervention Type BEHAVIORAL

2

ADA diet

Group Type ACTIVE_COMPARATOR

Low-fat, low-Glycemic Index, vegan diet

Intervention Type BEHAVIORAL

Interventions

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Low-fat, low-Glycemic Index, vegan diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Diabetes Action Research and Education Foundation

OTHER

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

Physicians Committee for Responsible Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal D Barnard, MD

Role: PRINCIPAL_INVESTIGATOR

Physicians Committee for Responsible Medicine

Locations

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Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Nicholson AS, Sklar M, Barnard ND, Gore S, Sullivan R, Browning S. Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. Prev Med. 1999 Aug;29(2):87-91. doi: 10.1006/pmed.1999.0529.

Reference Type BACKGROUND
PMID: 10446033 (View on PubMed)

Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ, Glass J. The effects of a low-fat, plant-based dietary intervention on body weight, metabolism, and insulin sensitivity. Am J Med. 2005 Sep;118(9):991-7. doi: 10.1016/j.amjmed.2005.03.039.

Reference Type BACKGROUND
PMID: 16164885 (View on PubMed)

Jenkins DJ, Kendall CW, Marchie A, Jenkins AL, Augustin LS, Ludwig DS, Barnard ND, Anderson JW. Type 2 diabetes and the vegetarian diet. Am J Clin Nutr. 2003 Sep;78(3 Suppl):610S-616S. doi: 10.1093/ajcn/78.3.610S.

Reference Type BACKGROUND
PMID: 12936955 (View on PubMed)

Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.

Reference Type RESULT
PMID: 16873779 (View on PubMed)

Turner-McGrievy GM, Barnard ND, Cohen J, Jenkins DJ, Gloede L, Green AA. Changes in nutrient intake and dietary quality among participants with type 2 diabetes following a low-fat vegan diet or a conventional diabetes diet for 22 weeks. J Am Diet Assoc. 2008 Oct;108(10):1636-45. doi: 10.1016/j.jada.2008.07.015.

Reference Type RESULT
PMID: 18926128 (View on PubMed)

Barnard ND, Gloede L, Cohen J, Jenkins DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009 Feb;109(2):263-72. doi: 10.1016/j.jada.2008.10.049.

Reference Type RESULT
PMID: 19167953 (View on PubMed)

Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Green A, Ferdowsian H. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-wk clinical trial. Am J Clin Nutr. 2009 May;89(5):1588S-1596S. doi: 10.3945/ajcn.2009.26736H. Epub 2009 Apr 1.

Reference Type RESULT
PMID: 19339401 (View on PubMed)

Barnard ND, Noble EP, Ritchie T, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Green AA, Ferdowsian H. D2 dopamine receptor Taq1A polymorphism, body weight, and dietary intake in type 2 diabetes. Nutrition. 2009 Jan;25(1):58-65. doi: 10.1016/j.nut.2008.07.012. Epub 2008 Oct 2.

Reference Type RESULT
PMID: 18834717 (View on PubMed)

Turner-McGrievy GM, Jenkins DJ, Barnard ND, Cohen J, Gloede L, Green AA. Decreases in dietary glycemic index are related to weight loss among individuals following therapeutic diets for type 2 diabetes. J Nutr. 2011 Aug;141(8):1469-74. doi: 10.3945/jn.111.140921. Epub 2011 Jun 8.

Reference Type DERIVED
PMID: 21653575 (View on PubMed)

Other Identifiers

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PCRM GWU DM Study

Identifier Type: -

Identifier Source: org_study_id