Practice Based Nutrition Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT01222429
First received: October 12, 2010
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

This study aims to test a dietary intervention for diabetes in a medical practice setting, with the aim of developing a model for diabetes care that can be used widely. The investigators hypothesize that a low-fat vegan diet will be effective for management of diabetes and will be feasible in a practice-based setting.


Condition Intervention
Type 2 Diabetes
Other: vegan diet
Other: diet following ADA 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

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: assessment at baseline (0 weeks) ] [ Designated as safety issue: No ]
  • hemoglobin A1C (diabetes management) [ Time Frame: assessment at 10 weeks ] [ Designated as safety issue: No ]
  • hemoglobin A1C (diabetes management) [ Time Frame: assessment at 20 weeks ] [ Designated as safety issue: No ]
  • hemoglobin A1C (diabetes management) [ Time Frame: assessment at one-year follow-up ] [ Designated as safety issue: No ]
  • lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) [ Time Frame: assessment at baseline (0 weeks) ] [ Designated as safety issue: No ]
  • lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) [ Time Frame: assessment at 10 weeks ] [ Designated as safety issue: No ]
  • lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) [ Time Frame: assesment at 20 weeks ] [ Designated as safety issue: No ]
  • lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) [ Time Frame: assessment at one-year follow-up ] [ Designated as safety issue: No ]
  • body weight [ Time Frame: assessment at baseline (0 weeks) ] [ Designated as safety issue: No ]
  • body weight [ Time Frame: assessment at 10 weeks ] [ Designated as safety issue: No ]
  • body weight [ Time Frame: assessment at 20 weeks ] [ Designated as safety issue: No ]
  • body weight [ Time Frame: assessment at one-year follow-up ] [ Designated as safety issue: No ]
  • indices of renal function (serum creatinine, microalbumin) [ Time Frame: assessment at baseline (0 weeks) ] [ Designated as safety issue: No ]
  • indices of renal function (serum creatinine, microalbumin) [ Time Frame: assessment at 10 weeks ] [ Designated as safety issue: No ]
  • indices of renal function (serum creatinine, microalbumin) [ Time Frame: assessment at 20 weeks ] [ Designated as safety issue: No ]
  • indices of renal function (serum creatinine, microalbumin) [ Time Frame: assessment at one-year follow-up ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2010
Study Completion Date: February 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: diet following American Diabetes Association guidelines
Participants will follow diets based on ADA guidelines. This group will also receive weekly nutrition classes.
Other: 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
Experimental: 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.
Other: 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

Detailed Description:

Specific Aim 1 tests the hypothesis that the nutrition intervention (low fat, low-GI vegan diet) improves glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in a within-group analysis.

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

  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 nutrition 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222429

Sponsors and Collaborators
Physicians Committee for Responsible Medicine
Investigators
Principal Investigator: Neal D Barnard, MD Washington Center for Clinical Research
  More Information

No publications provided

Responsible Party: Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier: NCT01222429     History of Changes
Other Study ID Numbers: PBNI-1
Study First Received: October 12, 2010
Last Updated: August 6, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014