A Practice-Based, Nutrition Intervention in Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Hemoglobin A1c
Study Overview
Brief Summary
The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 20 weeks with a one-year follow-up.
Detailed Description
Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. The investigators therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Type 2 Diabetes Mellitus
Exclusion Criteria
- •- hemoglobin A1c values <6.5% or >10.5% use of insulin for > 5 years tobacco use within the preceding 6 months consumption of more than 2 alcoholic beverages per day current drug abuse pregnancy unstable medical status current use of a low-fat, vegetarian diet.
Arms & Interventions
Low-fat, low-Glycemic Index, vegan diet
Low-fat, low-Glycemic Index, vegan diet
Intervention: Low-fat, low-Glycemic Index, vegan diet (Behavioral)
ADA diet
American Diabetes Association diet
Intervention: ADA diet (Behavioral)
Outcomes
Primary Outcomes
Hemoglobin A1c
Time Frame: 20 weeks
Secondary Outcomes
- Body Weight(20 Weeks)
- Glucose(20 Weeks)
- Comprehensive Metabolic Panel(20 Weeks & one-year follow up)
- Urinary albumin and creatinine(20 Weeks)
- Waist and hip circumference(20 Weeks)
- Dietary Acceptability(20 Weeks)
- Food Acceptability Questionnaire(20 Weeks)
- CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)(20 Weeks)
- Eating Inventory(20 Weeks)
- Beck Depression Inventory II (BDI-II)(20 Weeks)
- Blood Pressure(20 Weeks)
- International Physical Activity Questionnaire(20 Weeks)
- Serum cholesterol and triacylglycerol concentrations(20 Weeks)
- 3-day dietary records(20 Weeks)
- Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)(20 Weeks)