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

Physicians Committee for Responsible Medicine

Status

Suspended

Conditions

Diabetes Mellitus, Type 2

Treatments

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

Behavioral: ADA diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01931631

PCRM GWU DM Study-2

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 20 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. 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.

Enrollment

60 estimated 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.