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This study was never initiated.
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| Name | Class |
|---|---|
| George Washington University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-fat, low-Glycemic Index, vegan diet | Experimental | Low-fat, low-Glycemic Index, vegan diet |
|
| ADA diet | Active Comparator | American Diabetes Association diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-fat, low-Glycemic Index, vegan diet | Behavioral | Low-fat, low-Glycemic Index, vegan diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | 20 Weeks | |
| Blood Pressure | 20 Weeks | |
| Glucose |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Cohen, MD | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Committee for Responsible Medicine | Washington D.C. | District of Columbia | 20016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9863851 | Background | Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001. | |
| 10496449 | Background | Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8. |
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No data was collected because the study was never initiated.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| D000067269 | Diet, Vegan |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| ADA diet | Behavioral | Diet in accordance with the American Diabetes Association |
|
| 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 |
| 10446033 | Background | Nicholson AS, Sklar M, Barnard ND, Gore S, Sullivan R, Browning S. Toward improved management of NIDDM: A randomized, controlled, pilot intervention using a lowfat, vegetarian diet. Prev Med. 1999 Aug;29(2):87-91. doi: 10.1006/pmed.1999.0529. |
| D004700 | Endocrine System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D014676 | Diet, Vegetarian |
| D000095500 | Diet, Plant-Based |