Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Fat-Restricted, Glycemic Index
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.
Interventions
BEHAVIORALLow-fat, low-Glycemic Index, vegan diet
Low-fat, low-Glycemic Index, vegan diet
BEHAVIORALADA diet
Diet in accordance with the American Diabetes Association
Sponsors
George Washington University
Physicians Committee for Responsible Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c | 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Blood Pressure | 20 Weeks |
| Glucose | 20 Weeks |
| Comprehensive Metabolic Panel | 20 Weeks & one-year follow up |
| Serum cholesterol and triacylglycerol concentrations | 20 Weeks |
| Urinary albumin and creatinine | 20 Weeks |
| Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E) | 20 Weeks |
| Waist and hip circumference | 20 Weeks |
| Body Weight | 20 Weeks |
| 3-day dietary records | 20 Weeks |
| International Physical Activity Questionnaire | 20 Weeks |
| Food Acceptability Questionnaire | 20 Weeks |
| Eating Inventory | 20 Weeks |
| CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision) | 20 Weeks |
| Beck Depression Inventory II (BDI-II) | 20 Weeks |
| Dietary Acceptability | 20 Weeks |
Countries
United States
Outcome results
None listed