Plant-Based Dietary Intervention in Type 2 Diabetes-2

Not Applicable

Suspended

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Low-fat, low-Glycemic Index, vegan diet; Behavioral: ADA diet

• Registration Number: NCT01931631
• Lead Sponsor: Physicians Committee for Responsible Medicine

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.

Study Timeline

• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-08-29
• Study Start: 2014-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-01
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-fat, low-Glycemic Index, vegan diet	Low-fat, low-Glycemic Index, vegan diet	Low-fat, low-Glycemic Index, vegan diet
ADA diet	ADA diet	American Diabetes Association diet

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	20 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Physicians Committee for Responsible Medicine; 🇺🇸 Washington, District of Columbia, United States