Practice Based Nutrition Intervention-2 (PBNI-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT01700868
First received: October 2, 2012
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Other: Vegan diet
Other: American Diabetes Association guidelines

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Practice Based Nutrition Intervention-2

Resource links provided by NLM:


Further study details as provided by Physicians Committee for Responsible Medicine:

Primary Outcome Measures:
  • hemoglobin A1C (diabetes management) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body Weight [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Comprehensive Metabolic Panel [ Time Frame: 20 Weeks & one-year follow up ] [ Designated as safety issue: No ]
  • Serum cholesterol and triacylglycerol concentrations [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Urinary albumin and creatinine [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E) [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Waist and hip circumference [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Dietary Acceptability [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • 3-day dietary records [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • International Physical Activity Questionnaire [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Food Acceptability Questionnaire [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Eating Inventory [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision) [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory II (BDI-II) [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • Height [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
  • 24-Hour Multi-Pass Dietary Recalls [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Vegan diet
A diet devoid of any animal products. Low-fat, low-Glycemic Index, vegan diet.
Other Name: Plant-based diet
Active Comparator: American Diabetes Association guidelines
Participants will follow ADA diet according to ADA regulations. This group will also receive weekly nutrition classes.
Other: American Diabetes Association guidelines
Participants will follow individualized diet plans following ADA guidelines
Other Name: ADA

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  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 care
  7. diabetes medications unchanged for 1 month prior to volunteering for the study
  8. patient of Dr. Mark Sklar

Exclusion Criteria:

  1. body mass index >45 kg/m2
  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
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700868

Locations
United States, District of Columbia
Physicians Committee for Responsible Medicine
Washington, District of Columbia, United States, 20016
Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Investigators
Principal Investigator: Neal Barnard, MD Physicians Committee for Responsible Medicine
  More Information

Publications:
Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT01700868     History of Changes
Other Study ID Numbers: PBNI-2
Study First Received: October 2, 2012
Last Updated: September 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Physicians Committee for Responsible Medicine:
Diabetes Mellitus, Type 2
Diet, Vegetarian
Diet, Fat-Restricted
Glycemic Index

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014