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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-fat, low-Glycemic Index, vegan diet
ADA diet
Sponsored by
Physicians Committee for Responsible Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Fat-Restricted, Glycemic Index

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physicians Committee for Responsible Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-fat, low-Glycemic Index, vegan diet

ADA diet

Arm Description

Low-fat, low-Glycemic Index, vegan diet

American Diabetes Association diet

Outcomes

Primary Outcome Measures

Hemoglobin A1c

Secondary Outcome Measures

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

Full Information

First Posted
August 26, 2013
Last Updated
March 27, 2023
Sponsor
Physicians Committee for Responsible Medicine
Collaborators
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT01931631
Brief Title
Plant-Based Dietary Intervention in Type 2 Diabetes-2
Acronym
WCCR-DIAB2
Official Title
A Practice-Based, Nutrition Intervention in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Suspended
Why Stopped
Erroneously duplicated study
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physicians Committee for Responsible Medicine
Collaborators
George Washington University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Fat-Restricted, Glycemic Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-fat, low-Glycemic Index, vegan diet
Arm Type
Experimental
Arm Description
Low-fat, low-Glycemic Index, vegan diet
Arm Title
ADA diet
Arm Type
Active Comparator
Arm Description
American Diabetes Association diet
Intervention Type
Behavioral
Intervention Name(s)
Low-fat, low-Glycemic Index, vegan diet
Intervention Description
Low-fat, low-Glycemic Index, vegan diet
Intervention Type
Behavioral
Intervention Name(s)
ADA diet
Intervention Description
Diet in accordance with the American Diabetes Association
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Body Weight
Time Frame
20 Weeks
Title
Blood Pressure
Time Frame
20 Weeks
Title
Glucose
Time Frame
20 Weeks
Title
Comprehensive Metabolic Panel
Time Frame
20 Weeks & one-year follow up
Title
Serum cholesterol and triacylglycerol concentrations
Time Frame
20 Weeks
Title
Urinary albumin and creatinine
Time Frame
20 Weeks
Title
Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)
Time Frame
20 Weeks
Title
Waist and hip circumference
Time Frame
20 Weeks
Title
Dietary Acceptability
Time Frame
20 Weeks
Title
3-day dietary records
Time Frame
20 Weeks
Title
International Physical Activity Questionnaire
Time Frame
20 Weeks
Title
Food Acceptability Questionnaire
Time Frame
20 Weeks
Title
Eating Inventory
Time Frame
20 Weeks
Title
CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)
Time Frame
20 Weeks
Title
Beck Depression Inventory II (BDI-II)
Time Frame
20 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Cohen, MD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physicians Committee for Responsible Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
This study has been suspended
Citations:
PubMed Identifier
9863851
Citation
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.
Results Reference
background
PubMed Identifier
10496449
Citation
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.
Results Reference
background
PubMed Identifier
10446033
Citation
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.
Results Reference
background

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Plant-Based Dietary Intervention in Type 2 Diabetes-2

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