- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01700868
Practice Based Nutrition Intervention-2 (PBNI-2)
This study aims to test hypotheses that are potentially important to diabetes management, with practical implications for reducing the medical, personal, and economic costs of the disease. Anticipated outcomes include reductions in glycosylated hemoglobin that are significantly greater than those achievable with current diet recommendations, reductions in medication use among many intervention-group participants, beneficial changes in body weight and serum lipid concentrations, and a demonstration of the acceptability of the intervention diet. Progress toward these goals could refine dietary guidance for individuals with diabetes, increase treatment expectations, and reduce the massive burden the disease currently imposes.
The study further attempts to translate a dietary intervention studied in a clinical research setting to a medical practice. This will contribute to developing a model for diabetes care that can be used widely.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Specific Aim 1 tests the hypothesis that the nutrition intervention (low-fat, low-GI, vegan diet; henceforth called the 'vegan diet') improves glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in a within-group analysis.
Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose and urinary albumin and creatinine concentrations. The within-group changes in these variables from baseline to week 20, one-year follow-up will be compared.
Specific Aim 2 tests the hypothesis that the 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.
Glycosylated hemoglobin is the primary dependent variable, as well as fasting plasma glucose and urinary albumin and creatinine concentrations in both the intervention and control groups. The between-groups differences in the changes in these variables from baseline to week 20, and one-year follow-up will be compared.
Specific Aim 3 tests the hypothesis that the 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.
This will be assessed by 3-day dietary records at weeks 0, 20 and one-year follow-up.
Specific Aim 4 tests the hypothesis that the vegan diet has an acceptability that is comparable to that of standard nutrition care among individuals with type 2 diabetes.
This hypothesis will be addressed by quantitatively assessing adherence to and acceptability of the intervention and control diets, using the 3-day dietary record, the Food Acceptability Questionnaire, and the Eating Inventory, as described below.
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 and B1 alleles of the DRD2 gene.
This will be assessed through Taq1 A1 and B1 genotype determination at baseline.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20016
- Physicians Committee for Responsible Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥126 mg/dl on 2 occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least 6 months
- male or female
- A1c between 6.5% and 10.5%
- age at least 18 years
- ability and willingness to participate in all components of the study
- willingness to be assigned to either a low-fat, vegan diet or to standard care
- diabetes medications unchanged for 1 month prior to volunteering for the study
- patient of Dr. Mark Sklar
Exclusion Criteria:
- body mass index >45 kg/m2
- 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
- use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
- pregnancy
- history of severe mental illness (with current unstable status)
- likely to be disruptive in group sessions (as determined by research staff)
- Signs/symptoms of acute uncontrolled diabetes (including but not limited to polyuria, polydipsia, blurred vision, uncontrolled weight loss)
- unstable medical status
- already following a low-fat, vegetarian diet
- an inordinate fear of blood draws
- inability to maintain current medication regimen
- lack of English fluency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vegan Group
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.
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A diet devoid of any animal products.
Low-fat, low-Glycemic Index, vegan diet.
Other Names:
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Active Comparator: American Diabetes Association guidelines
Participants will follow ADA diet according to ADA regulations.
This group will also receive weekly nutrition classes.
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Participants will follow individualized diet plans following ADA guidelines
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hemoglobin A1C (diabetes management)
Time Frame: 20 weeks
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20 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body Weight
Time Frame: 20 Weeks
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20 Weeks
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Blood Pressure
Time Frame: 20 Weeks
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20 Weeks
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Glucose
Time Frame: 20 Weeks
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20 Weeks
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Comprehensive Metabolic Panel
Time Frame: 20 Weeks & one-year follow up
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20 Weeks & one-year follow up
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Serum cholesterol and triacylglycerol concentrations
Time Frame: 20 Weeks
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20 Weeks
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Urinary albumin and creatinine
Time Frame: 20 Weeks
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20 Weeks
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Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)
Time Frame: 20 Weeks
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20 Weeks
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Waist and hip circumference
Time Frame: 20 Weeks
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20 Weeks
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Dietary Acceptability
Time Frame: 20 Weeks
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20 Weeks
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3-day dietary records
Time Frame: 20 Weeks
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20 Weeks
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International Physical Activity Questionnaire
Time Frame: 20 Weeks
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20 Weeks
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Food Acceptability Questionnaire
Time Frame: 20 Weeks
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20 Weeks
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Eating Inventory
Time Frame: 20 Weeks
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20 Weeks
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CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)
Time Frame: 20 Weeks
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20 Weeks
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Beck Depression Inventory II (BDI-II)
Time Frame: 20 Weeks
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20 Weeks
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Height
Time Frame: 20 Weeks
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20 Weeks
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24-Hour Multi-Pass Dietary Recalls
Time Frame: 20 Weeks
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20 Weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Neal Barnard, MD, Physicians Committee for Responsible Medicine
Publications and helpful links
General Publications
- Nicholson AS, Sklar M, Barnard ND, Gore S, Sullivan R, Browning S. Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. Prev Med. 1999 Aug;29(2):87-91. doi: 10.1006/pmed.1999.0529.
- Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001. Erratum In: JAMA 1999 Apr 21;281(15):1380.
- Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBNI-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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