Practice Based Nutrition Intervention-2

NCT01700868 | Completed DMC

• 1 other identifier: PBNI-2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Diet, Vegetarian; Diet, Fat-Restricted; Glycemic Index

Outcome Measures

Primary Outcomes (1)

• hemoglobin A1C (diabetes management)

  20 weeks

Secondary Outcomes (17)

• Body Weight

  20 Weeks

• Blood Pressure

  20 Weeks

• Glucose

  20 Weeks

• Comprehensive Metabolic Panel

  20 Weeks & one-year follow up

• Serum cholesterol and triacylglycerol concentrations

  20 Weeks

Study Arms (2)

Vegan Group

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

American Diabetes Association guidelines

ACTIVE COMPARATOR

Participants will follow ADA diet according to ADA regulations. This group will also receive weekly nutrition classes.

Other: American Diabetes Association guidelines

Interventions

Vegan diet OTHER

A diet devoid of any animal products. Low-fat, low-Glycemic Index, vegan diet.

Also known as: Plant-based diet

Vegan Group

American Diabetes Association guidelines OTHER

Participants will follow individualized diet plans following ADA guidelines

Also known as: ADA

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 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
• 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

Study Sites (1)

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (3)

• 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.

  PMID: 9863851 BACKGROUND

• 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.

  PMID: 10496449 BACKGROUND

• 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.

  PMID: 10446033 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Vegan; Diet, Plant-Based

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Neal Barnard, MD

  Physicians Committee for Responsible Medicine

  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 2, 2012
• First Posted: October 4, 2012
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

US (1)