Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diet following American Diabetes Association guidelines | Active Comparator | Participants will follow diets based on ADA guidelines. This group will also receive weekly nutrition classes. |
|
| vegan diet | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vegan diet | Other | Intervention group participants will follow a low-fat vegan diet and will receive instruction on this diet through the course of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| hemoglobin A1C (diabetes management) | assessment at baseline (0 weeks) | |
| hemoglobin A1C (diabetes management) | assessment at 10 weeks | |
| hemoglobin A1C (diabetes management) | assessment at 20 weeks | |
| hemoglobin A1C (diabetes management) | assessment at one-year follow-up | |
| lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) | assessment at baseline (0 weeks) | |
| lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) | assessment at 10 weeks | |
| lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) | assesment at 20 weeks | |
| lipid profile (serum cholesterol--total, LDL, HDL; triglycerides) | assessment at one-year follow-up | |
| body weight | assessment at baseline (0 weeks) | |
| body weight | assessment at 10 weeks | |
| body weight |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neal D Barnard, MD | Washington Center for Clinical Research | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29398571 | Derived | Barnard ND, Levin SM, Gloede L, Flores R. Turning the Waiting Room into a Classroom: Weekly Classes Using a Vegan or a Portion-Controlled Eating Plan Improve Diabetes Control in a Randomized Translational Study. J Acad Nutr Diet. 2018 Jun;118(6):1072-1079. doi: 10.1016/j.jand.2017.11.017. Epub 2018 Feb 15. |
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000067269 | Diet, Vegan |
| ID | Term |
|---|---|
| D014676 | Diet, Vegetarian |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| diet following ADA guidelines | Other | participants will be given instruction on the ADA guidelines for diabetes, and will follow an individualized plan based on these guidelines |
|
| assessment at 20 weeks |
| body weight | assessment at one-year follow-up |
| indices of renal function (serum creatinine, microalbumin) | assessment at baseline (0 weeks) |
| indices of renal function (serum creatinine, microalbumin) | assessment at 10 weeks |
| indices of renal function (serum creatinine, microalbumin) | assessment at 20 weeks |
| indices of renal function (serum creatinine, microalbumin) | assessment at one-year follow-up |
| D004700 | Endocrine System Diseases |
| D013812 |
| Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |