NCT01931631

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 20 weeks with a one-year follow-up.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

3.9 years

First QC Date

August 26, 2013

Last Update Submit

June 27, 2025

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2Diet, VegetarianDiet, Fat-RestrictedGlycemic Index

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    20 weeks

Secondary Outcomes (15)

  • 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

  • +10 more secondary outcomes

Study Arms (2)

Low-fat, low-Glycemic Index, vegan diet

EXPERIMENTAL

Low-fat, low-Glycemic Index, vegan diet

Behavioral: Low-fat, low-Glycemic Index, vegan diet

ADA diet

ACTIVE COMPARATOR

American Diabetes Association diet

Behavioral: ADA diet

Interventions

Low-fat, low-Glycemic Index, vegan dietBEHAVIORAL

Low-fat, low-Glycemic Index, vegan diet

Low-fat, low-Glycemic Index, vegan diet
ADA dietBEHAVIORAL

Diet in accordance with the American Diabetes Association

ADA diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Type 2 Diabetes Mellitus

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (3)

  • 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.

    PMID: 9863851BACKGROUND

  • 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.

    PMID: 10496449BACKGROUND

  • 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.

    PMID: 10446033BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Fat-RestrictedDiet, Vegan

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDiet, VegetarianDiet, Plant-Based

Study Officials

  • Joshua Cohen, MD

    George Washington University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2013

First Posted

August 29, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

No data was collected because the study was never initiated.

Locations

US(1)