Plant-Based Dietary Intervention in Type 2 Diabetes-2 (WCCR-DIAB2)

A Practice-Based, Nutrition Intervention in Type 2 Diabetes

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 20 weeks with a one-year follow-up.

Study Overview

• Status: Suspended
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Low-fat, low-Glycemic Index, vegan diet; Behavioral: ADA 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. The investigators 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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Physicians Committee for Responsible Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-fat, low-Glycemic Index, vegan diet	Behavioral: Low-fat, low-Glycemic Index, vegan diet; Low-fat, low-Glycemic Index, vegan diet
Active Comparator: ADA diet; American Diabetes Association diet	Behavioral: ADA diet; Diet in accordance with the American Diabetes Association

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin A1c	20 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Body Weight	20 Weeks
Blood Pressure	20 Weeks
Glucose	20 Weeks
Comprehensive Metabolic Panel	20 Weeks & one-year follow up
Serum cholesterol and triacylglycerol concentrations	20 Weeks
Urinary albumin and creatinine	20 Weeks
Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)	20 Weeks
Waist and hip circumference	20 Weeks
Dietary Acceptability	20 Weeks
3-day dietary records	20 Weeks
International Physical Activity Questionnaire	20 Weeks
Food Acceptability Questionnaire	20 Weeks
Eating Inventory	20 Weeks
CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)	20 Weeks
Beck Depression Inventory II (BDI-II)	20 Weeks

Collaborators and Investigators

• Sponsor: Physicians Committee for Responsible Medicine
• Collaborators: George Washington University
• Investigators: Principal Investigator: Joshua Cohen, MD, George Washington University

Publications and helpful links

General 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. doi: 10.1006/pmed.1999.0529.
• Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001. Erratum In: JAMA 1999 Apr 21;281(15):1380.
• Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: August 26, 2013
• First Submitted That Met QC Criteria: August 28, 2013
• First Posted (Estimated): August 29, 2013

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus, Type 2; Diet, Vegetarian; Diet, Fat-Restricted; Glycemic Index
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PCRM GWU DM Study-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This study has been suspended