Plant-Based Dietary Intervention in Type 2 Diabetes-2



Status:Suspended
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:January 2014
End Date:January 2021

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A Practice-Based, Nutrition Intervention in Type 2 Diabetes

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.

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.

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.
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Washington, District of Columbia 20016
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