Plant-Based Dietary Intervention in Type 2 Diabetes - Full Text View

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

MedlinePlus related topics:

Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Plant-Based Dietary Intervention in Type 2 Diabetes

Further study details as provided by The Washington Center for Clinical Research:

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
1: Experimental Low-fat, low-Glycemic Index, vegan diet	Behavioral: Low-fat, low-Glycemic Index, vegan diet
2: Active Comparator 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

The Washington Center for Clinical Research

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

More Information

Publications of Results:

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.

Other Publications:

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.

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.

Turner-McGrievy GM, Barnard ND, Scialli AR, Lanou AJ. Effects of a low-fat vegan diet and a Step II diet on macro- and micronutrient intakes in overweight postmenopausal women. Nutrition. 2004 Sep;20(9):738-46.

Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ. Acceptability of a low-fat vegan diet compares favorably to a step II diet in a randomized, controlled trial. J Cardiopulm Rehabil. 2004 Jul-Aug;24(4):229-35.

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. Review.

Responsible Party:	Physicians Committee for Responsible Medicine ( Neal Barnard, MD )
Study ID Numbers:	PCRM GWU DM Study
First Received:	January 11, 2006
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00276939
Health Authority:	United States: Institutional Review Board

Keywords provided by The Washington Center for Clinical Research:

Diabetes Mellitus, Type 2

Diet, Vegetarian

Diet, Fat-Restricted

Glycemic Index

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 04, 2008

Sponsors and Collaborators:	The Washington Center for Clinical Research 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:	The Washington Center for Clinical Research
ClinicalTrials.gov Identifier:	NCT00276939