Plant-Based Dietary Intervention in Type 2 Diabetes-2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Low-fat, low-Glycemic Index, vegan diet

Group Type EXPERIMENTAL

Low-fat, low-Glycemic Index, vegan diet

Intervention Type BEHAVIORAL

Low-fat, low-Glycemic Index, vegan diet

ADA diet

American Diabetes Association diet

Group Type ACTIVE_COMPARATOR

ADA diet

Intervention Type BEHAVIORAL

Diet in accordance with the American Diabetes Association

Interventions

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Low-fat, low-Glycemic Index, vegan diet

Intervention Type BEHAVIORAL

ADA diet

Diet in accordance with the American Diabetes Association

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No