Plant-Based Dietary Intervention in Type 2 Diabetes

Physicians Committee for Responsible Medicine

Status: Completed

Conditions: Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00276939

PCRM GWU DM Study

Details and patient eligibility

About

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 22 weeks with a one-year follow-up.

Full 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. We 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

1

Experimental group

Description:

Low-fat, low-Glycemic Index, vegan diet

Treatment:

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

2

Active Comparator group

Description:

ADA diet

Treatment:

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