Practice Based Nutrition Intervention

Type 2 Diabetes Clinical Trial

Official title:

Practice-Based Nutrition Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222429
• Other study ID #: PBNI-1
• Status: Completed
• Phase: N/A
• First received: October 12, 2010
• Last updated: August 6, 2012
• Start date: October 2010
• Est. completion date: February 2012

Study information

• Verified date: August 2012
• Source: Physicians Committee for Responsible Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Physicians Committee for Responsible Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin A1C (diabetes management)		assessment at baseline (0 weeks)	No
Primary	hemoglobin A1C (diabetes management)		assessment at 10 weeks	No
Primary	hemoglobin A1C (diabetes management)		assessment at 20 weeks	No
Primary	hemoglobin A1C (diabetes management)		assessment at one-year follow-up	No
Primary	lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)		assessment at baseline (0 weeks)	No
Primary	lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)		assessment at 10 weeks	No
Primary	lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)		assesment at 20 weeks	No
Primary	lipid profile (serum cholesterol--total, LDL, HDL; triglycerides)		assessment at one-year follow-up	No
Primary	body weight		assessment at baseline (0 weeks)	No
Primary	body weight		assessment at 10 weeks	No
Primary	body weight		assessment at 20 weeks	No
Primary	body weight		assessment at one-year follow-up	No
Primary	indices of renal function (serum creatinine, microalbumin)		assessment at baseline (0 weeks)	No
Primary	indices of renal function (serum creatinine, microalbumin)		assessment at 10 weeks	No
Primary	indices of renal function (serum creatinine, microalbumin)		assessment at 20 weeks	No
Primary	indices of renal function (serum creatinine, microalbumin)		assessment at one-year follow-up	No