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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK126898-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study is being completed to compare two dietary approaches for participants with type 2 diabetes. This research will test whether a very low-carbohydrate or a plate-method diet better improves outcomes for blood glucose control and body composition for patients with type 2 diabetes that follow one of these approaches for 12 months.
Participants that meet screening and eligibility will be randomized to one of the two diets. In addition to the diet, study specific visits and assessments will be performed at various timepoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Very low-carbohydrate diet | Experimental |
| |
| Moderate-carbohydrate plate-method diet | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low-carbohydrate diet | Behavioral | Participants in this arm will be taught to manage their type 2 diabetes using a very low-carbohydrate diet, also called a ketogenic or "keto" diet. This diet involves eating non-starchy vegetables, leafy greens, cheese, meats, berries, nuts, and seeds and avoiding starchy foods like pasta, bread, rice, beans, many fruits, etc. There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | HbA1c will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab. | 0 to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammation based on high sensitivity C-reactive protein (hsCRP) | High-sensitivity C-reactive protein will be measured with nephelometric methods utilizing latex particles coated with CRP monoclonal antibodies and standardized against a CRP reference preparation. | 0 to 12 months |
| Change in small particle low-density lipoproteins (LDL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Saslow, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of California San Francisco (UCSF) | San Francisco | California | 94143 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37475033 | Derived | Saslow LR, Eslamian A, Moran P, Hartogensis W, Mason AE, Kim S, Bauer DC, Griauzde DH, Goldman V, Liu V, Stephens P, Raymond K, Yeung G, Leung C, Hecht FM. Protocol for a randomized controlled trial comparing a very low-carbohydrate diet or moderate-carbohydrate plate-method diet for type 2 diabetes: the LEGEND (Lifestyle Education about Nutrition for Diabetes) trial. Trials. 2023 Jul 20;24(1):463. doi: 10.1186/s13063-023-07512-9. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2025 | Nov 5, 2025 | ICF_000.pdf |
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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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Outcome assessment and data analysis will be masked.
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| Moderate-carbohydrate plate-method diet | Behavioral | Participants in this arm will be taught to manage their type 2 diabetes using a plate-method approach. This diet involves eating different categories of foods based on the proportions of a plate, balancing proteins, vegetables, fruits, starches, and fats. There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month. |
|
| 0 to 12 months |
| Change in high-density lipoproteins (HDL) | 0 to 12 months |
| Change in triglycerides | 0 to 12 months |
| Change in percent body weight loss | 0 to 12 months |
| Change in percent body fat on DEXA | This will be measured by dual-energy X-ray absorptiometry scan | 0 to 12 months |
| Change in percent lean body mass on DEXA | This will be measured by dual-energy X-ray absorptiometry scan | 0 to 12 months |
| Change in bone mineral density in total hip | This will be measured by dual-energy X-ray absorptiometry scan | 0 to 12 months |
| Change in bone mineral density in lumbar spine | This will be measured by dual-energy X-ray absorptiometry scan | 0 to 12 months |
| Change in serum procollagen type I N propeptide (s-PINP) | 0 to 12 months |
| Change in serum c-terminal telopeptide of type 1 collagen (s-CTX) | 0 to 12 months |
| Reduction in diabetes medications using medication effect score (MES) | The medication effect score is a means of assessing the overall intensity of a patient's diabetes pharmacotherapy based on potency and dosages of medications (Alexopoulos et al., 2021). | 0 to 12 months |
| Change in HbA1c | HbA1c will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab. | 0 to 4 months |
| University of MIchigan |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| D004700 | Endocrine System Diseases |