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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Diabetes Action Research and Education Foundation | OTHER |
| 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 22 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. We 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 |
|---|---|---|---|
| 1 | Experimental | Low-fat, low-Glycemic Index, vegan diet |
|
| 2 | Active Comparator | ADA diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-fat, low-Glycemic Index, vegan diet | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | 22 weeks | |
| Plasma lipid concentrations | 22 weeks | |
| Urinary albumin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal D Barnard, MD | Physicians Committee for Responsible Medicine | 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 |
|---|---|---|---|
| 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. | |
| 16164885 | Background | Barnard ND, Scialli AR, Turner-McGrievy G, Lanou AJ, Glass J. The effects of a low-fat, plant-based dietary intervention on body weight, metabolism, and insulin sensitivity. Am J Med. 2005 Sep;118(9):991-7. doi: 10.1016/j.amjmed.2005.03.039. |
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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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| University of Toronto |
| OTHER |
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| 22 weeks |
| Dietary Acceptability | 22 weeks |
| 12936955 | Background | Jenkins DJ, Kendall CW, Marchie A, Jenkins AL, Augustin LS, Ludwig DS, Barnard ND, Anderson JW. Type 2 diabetes and the vegetarian diet. Am J Clin Nutr. 2003 Sep;78(3 Suppl):610S-616S. doi: 10.1093/ajcn/78.3.610S. |
| 16873779 | Result | Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606. |
| 18926128 | Result | Turner-McGrievy GM, Barnard ND, Cohen J, Jenkins DJ, Gloede L, Green AA. Changes in nutrient intake and dietary quality among participants with type 2 diabetes following a low-fat vegan diet or a conventional diabetes diet for 22 weeks. J Am Diet Assoc. 2008 Oct;108(10):1636-45. doi: 10.1016/j.jada.2008.07.015. |
| 19167953 | Result | Barnard ND, Gloede L, Cohen J, Jenkins DJ, Turner-McGrievy G, Green AA, Ferdowsian H. A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes. J Am Diet Assoc. 2009 Feb;109(2):263-72. doi: 10.1016/j.jada.2008.10.049. |
| 19339401 | Result | Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Green A, Ferdowsian H. A low-fat vegan diet and a conventional diabetes diet in the treatment of type 2 diabetes: a randomized, controlled, 74-wk clinical trial. Am J Clin Nutr. 2009 May;89(5):1588S-1596S. doi: 10.3945/ajcn.2009.26736H. Epub 2009 Apr 1. |
| 18834717 | Result | Barnard ND, Noble EP, Ritchie T, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Green AA, Ferdowsian H. D2 dopamine receptor Taq1A polymorphism, body weight, and dietary intake in type 2 diabetes. Nutrition. 2009 Jan;25(1):58-65. doi: 10.1016/j.nut.2008.07.012. Epub 2008 Oct 2. |
| 21653575 | Derived | Turner-McGrievy GM, Jenkins DJ, Barnard ND, Cohen J, Gloede L, Green AA. Decreases in dietary glycemic index are related to weight loss among individuals following therapeutic diets for type 2 diabetes. J Nutr. 2011 Aug;141(8):1469-74. doi: 10.3945/jn.111.140921. Epub 2011 Jun 8. |
| D004700 | Endocrine System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D014676 | Diet, Vegetarian |
| D000095500 | Diet, Plant-Based |