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Completed

NCT Number: NCT00276939

Plant-Based Dietary 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 22 weeks with a one-year follow-up.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-fat, low-Glycemic Index, vegan diet

Behavioral

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 22 weeks

Secondary outcomes

  1. Body weight

    Time frame: 22 weeks

  2. Plasma lipid concentrations

    Time frame: 22 weeks

  3. Urinary albumin

    Time frame: 22 weeks

  4. Dietary Acceptability

    Time frame: 22 weeks

Sponsors and collaborators

Lead sponsor

Physicians Committee for Responsible Medicine

Other

Collaborators

  • Diabetes Action Research and Education Foundation
  • George Washington University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Toronto

Registry information

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Jan 13, 2006
Registry last updated
Aug 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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