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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK125792-01A1 | 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 research will test whether a standard version or very low-carbohydrate version of the Diabetes Prevention Program better improves outcomes like blood glucose control and body weight for patients with prediabetes.
Participants will have screening (includes blood draw) and baseline testing with a continuous glucose monitor. Once these enrollment steps are completed and the participants will be randomized to one of two groups: standard National Diabetes Prevention Program (NDPP) or a very low-carbohydrate version.
In addition to the diet (12 months) participants will be asked to participate in hour-long weekly group classes over zoom. After four months in the program, classes will occur about every month to help participants maintain the new diet. There will also be check-ins and follow-up visits through out the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard NDPP | Active Comparator | 12-month long, calorie-restricted NDPP |
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| Very low-carbohydrate diet (VLCD) | Experimental | VLCD is an adaptation of the standard NDPP curriculum, which preserves all features with the exception of altered dietary advice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard NDPP | Behavioral | Participants in this arm will be taught to manage their prediabetes with the Centers for Disease Control's standard National Diabetes Prevention Program. It teaches a lower calorie, lower fat diet. 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 levels 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 C-reactive protein (CRP) | 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 percent body weight loss |
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Inclusion Criteria:
Exclusion Criteria:
history of type 1 diabetes or type 2 diabetes
use of anti-obesity medications or participation in another weight loss program or intervention
use of glucose lowering medications other than metformin
pregnant or planning to become pregnant during the intervention period
breastfeeding
use of oral corticosteroids
previous bariatric surgery or planning to have bariatric surgery during the study period
blood disorders that influence HbA1c, including frequent blood transfusions, phlebotomy, anemia, hemoglobinopathy, polycythemia
any condition for which the study team deems participation to be unsafe or inappropriate
inability to read, write, or speak English
inability to provide informed consent
adherence to a vegan or vegetarian diet
adherence to a very low-carbohydrate (keto) diet
difficulty chewing or swallowing
no influence over what foods are purchased, prepared, and/or served
above weight limit for DEXA (500 pounds)
untreated eating disorder or mental health conditions, such as depression with suicidal ideation, bipolar or schizophrenia with psychosis
use of warfarin
chronic kidney disease, stage 4 or higher
use of loop diuretics: 20mg or higher of furosemide or equivalent (Lasix (furosemide), Bumex (bumetanide), Ederin or Sodium Edecrin (ethacrynic acid), Demadex or Soaanz (torsemide))
any concerning values in baseline labs (participants will be referred to Primary Care Physician and will be allowed to return for later enrollment if labs are no longer concerning)
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| Name | Affiliation | Role |
|---|---|---|
| Laura Saslow, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36176003 | Derived | Griauzde DH, O'Brien A, Yancy WS Jr, Richardson CR, Krinock J, DeJonckheere M, Isaman DJM, Vanias K, Shopinski S, Saslow LR. Testing a very low-carbohydrate adaption of the Diabetes Prevention Program among adults with prediabetes: study protocol for the Lifestyle Education about prediabetes (LEAP) trial. Trials. 2022 Sep 30;23(1):827. doi: 10.1186/s13063-022-06770-3. |
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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 | Sep 12, 2024 | Nov 5, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| 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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| Very low-carbohydrate diet | Behavioral | Participants in this arm will be taught to manage their prediabetes with the Centers for Disease Control's National Diabetes Prevention Program, adapted to teach 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. |
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| 0-12 months |
| Change in glycemic variability | This will be measured with an Abbott Libre Pro continuous glucose monitoring device on participants upper arm and the information on the sensor is blinded to participants. The monitoring device will record participants' glucose levels in the interstitial fluid by a glucose oxidase method every 15 minutes, continuously for 14 days at each time point. T The glucose variability and the proportion of time spent in the euglycemic (3-7.8 millimoles per litre (mmol/l)) and hyperglycemic (≥ 11.1 mmol/l for at least 15 minutes) states, following previous standards for interstitial glucose concentrations. | 0 to 12 months |
| Change in small particle low-density lipoproteins (LDL) | 0 to 12 months |
| Change in high-density lipoproteins (HDL) | 0 to 12 months |
| Change in triglycerides | 0 to 12 months |
| Change in HbA1c | HbA1c levels 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 |
| D004700 | Endocrine System Diseases |