Plant-Based Dietary Intervention in Type 2 Diabetes-2

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.

Official Title
-----------------
A Practice-Based, Nutrition Intervention in Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Low-fat, low-Glycemic Index, vegan diet
* Behavioral: ADA diet


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-fat, low-Glycemic Index, vegan diet<br>Low-fat, low-Glycemic Index, vegan diet | Behavioral: Low-fat, low-Glycemic Index, vegan diet<br>* Low-fat, low-Glycemic Index, vegan diet<br>|
| Active Comparator: ADA diet<br>American Diabetes Association diet | Behavioral: ADA diet<br>* Diet in accordance with the American Diabetes Association<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Dietary Acceptability |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Type 2, Diet, Vegetarian, Diet, Fat-Restricted, Glycemic Index