Practice Based Nutrition Intervention

NCT01222429 | Completed

• 1 other identifier: PBNI-1
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (16)

• hemoglobin A1C (diabetes management)

  assessment at baseline (0 weeks)

• hemoglobin A1C (diabetes management)

  assessment at 10 weeks

• hemoglobin A1C (diabetes management)

  assessment at 20 weeks

• hemoglobin A1C (diabetes management)

  assessment at one-year follow-up

• lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)

  assessment at baseline (0 weeks)

• lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)

  assessment at 10 weeks

• lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)

  assesment at 20 weeks

• lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)

  assessment at one-year follow-up

• body weight

  assessment at baseline (0 weeks)

• body weight

  assessment at 10 weeks

• body weight

  assessment at 20 weeks

• body weight

  assessment at one-year follow-up

• indices of renal function (serum creatinine, microalbumin)

  assessment at baseline (0 weeks)

• indices of renal function (serum creatinine, microalbumin)

  assessment at 10 weeks

• indices of renal function (serum creatinine, microalbumin)

  assessment at 20 weeks

• indices of renal function (serum creatinine, microalbumin)

  assessment at one-year follow-up

Study Arms (2)

diet following American Diabetes Association guidelines

ACTIVE COMPARATOR

Participants will follow diets based on ADA guidelines. This group will also receive weekly nutrition classes.

Other: diet following ADA guidelines

vegan diet

EXPERIMENTAL

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

Interventions

vegan diet OTHER

Intervention group participants will follow a low-fat vegan diet and will receive instruction on this diet through the course of the study

vegan diet

diet following ADA guidelines OTHER

participants will be given instruction on the ADA guidelines for diabetes, and will follow an individualized plan based on these guidelines

diet following American Diabetes Association guidelines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• pregnancy or plans to become pregnant
• 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

Sponsors & Collaborators

• Physicians Committee for Responsible Medicine: lead

Related Publications (1)

• 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.

  PMID: 29398571 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Vegan

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Neal D Barnard, MD

  Washington Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 18, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: February 1, 2012
• Last Updated: August 7, 2012

Record last verified: 2012-08