Plant-Based Dietary Intervention in Type 2 Diabetes-2

Diabetes Mellitus, Type 2 Clinical Trial

— WCCR-DIAB2  

Official title:

A Practice-Based, Nutrition Intervention in Type 2 Diabetes

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01931631
• Other study ID #: PCRM GWU DM Study-2
• Status: Suspended
• Phase: N/A
• Start date: January 2014
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: April 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Low-fat, low-Glycemic Index, vegan diet
Low-fat, low-Glycemic Index, vegan diet
• ADA diet
Diet in accordance with the American Diabetes Association

Locations

Country	Name	City	State
United States	Physicians Committee for Responsible Medicine	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine	George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c		20 weeks
Secondary	Body Weight		20 Weeks
Secondary	Blood Pressure		20 Weeks
Secondary	Glucose		20 Weeks
Secondary	Comprehensive Metabolic Panel		20 Weeks & one-year follow up
Secondary	Serum cholesterol and triacylglycerol concentrations		20 Weeks
Secondary	Urinary albumin and creatinine		20 Weeks
Secondary	Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)		20 Weeks
Secondary	Waist and hip circumference		20 Weeks
Secondary	Dietary Acceptability		20 Weeks
Secondary	3-day dietary records		20 Weeks
Secondary	International Physical Activity Questionnaire		20 Weeks
Secondary	Food Acceptability Questionnaire		20 Weeks
Secondary	Eating Inventory		20 Weeks
Secondary	CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)		20 Weeks
Secondary	Beck Depression Inventory II (BDI-II)		20 Weeks