Study Results
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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COMPLETED
NA
50 participants
INTERVENTIONAL
2010-10-31
2012-02-29
Brief Summary
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Detailed Description
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Specific Aim 2 tests the hypothesis that the nutrition intervention (low fat, low-GI vegan diet) is more effective than standard nutrition care for improving glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in individuals with type 2 diabetes
Specific Aim 3 tests the hypothesis that a low-fat vegan diet is sustainable among individuals with type 2 diabetes for a 20-week period, with weekly classes, and in a follow-up period of one year with limited professional support.
Specific Aim 4 tests the hypothesis that a low-fat vegan diet has an acceptability that is comparable to that of standard nutrition care among individuals with type 2 diabetes.
Specific Aim 5 tests the hypothesis that the effects of the dietary interventions on A1c and body weight are reduced in individuals with the A1 allele of the Taq1A and Taq1B polymorphism
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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diet following American Diabetes Association guidelines
Participants will follow diets based on ADA guidelines. This group will also receive weekly nutrition classes.
diet following ADA guidelines
participants will be given instruction on the ADA guidelines for diabetes, and will follow an individualized plan based on these guidelines
vegan diet
Participants in the intervention group will follow a low-fat, vegan diet for 20 weeks, and will attend nutrition classes in the form of a weekly support group.
vegan diet
Intervention group participants will follow a low-fat vegan diet and will receive instruction on this diet through the course of the study
Interventions
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vegan diet
Intervention group participants will follow a low-fat vegan diet and will receive instruction on this diet through the course of the study
diet following ADA guidelines
participants will be given instruction on the ADA guidelines for diabetes, and will follow an individualized plan based on these guidelines
Eligibility Criteria
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Inclusion Criteria
2. male or female
3. A1c between 6.5% and 10.5%
4. age at least 18 years
5. ability and willingness to participate in all components of the study
6. willingness to be assigned to either a low-fat, vegan diet or to standard nutrition care
7. diabetes medications unchanged for 1 month prior to volunteering for the study
8. patient of Dr. Mark Sklar
Exclusion Criteria
2. alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
3. use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
4. pregnancy or plans to become pregnant
5. history of severe mental illness (with current unstable status)
6. likely to be disruptive in group sessions (as determined by research staff)
7. Signs/symptoms of acute uncontrolled diabetes (including but not limited to polyuria, polydipsia, blurred vision, uncontrolled weight loss)
8. unstable medical status
9. already following a low-fat, vegetarian diet
10. an inordinate fear of blood draws
11. inability to maintain current medication regimen
12. lack of English fluency
18 Years
ALL
No
Sponsors
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Physicians Committee for Responsible Medicine
OTHER
Responsible Party
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Principal Investigators
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Neal D Barnard, MD
Role: PRINCIPAL_INVESTIGATOR
Washington Center for Clinical Research
Countries
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References
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Barnard ND, Levin SM, Gloede L, Flores R. Turning the Waiting Room into a Classroom: Weekly Classes Using a Vegan or a Portion-Controlled Eating Plan Improve Diabetes Control in a Randomized Translational Study. J Acad Nutr Diet. 2018 Jun;118(6):1072-1079. doi: 10.1016/j.jand.2017.11.017. Epub 2018 Feb 15.
Other Identifiers
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PBNI-1
Identifier Type: -
Identifier Source: org_study_id