The Lifestyle Education About Nutrition for Diabetes (Legend) Study (LEGEND)
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| ClinicalTrials.gov Identifier: NCT05237128 |
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Recruitment Status :
Recruiting
First Posted : February 11, 2022
Last Update Posted : May 24, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes | Behavioral: Very low-carbohydrate diet Behavioral: Moderate-carbohydrate plate-method diet | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | Outcome assessment and data analysis will be masked. |
| Primary Purpose: | Treatment |
| Official Title: | Comparing Two Dietary Approaches for Type 2 Diabetes: The LEGEND (Lifestyle Education About Nutrition for Diabetes) Study |
| Actual Study Start Date : | March 22, 2022 |
| Estimated Primary Completion Date : | July 2025 |
| Estimated Study Completion Date : | July 2025 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Very low-carbohydrate diet |
Behavioral: Very low-carbohydrate diet
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. |
| Experimental: Moderate-carbohydrate plate-method diet |
Behavioral: Moderate-carbohydrate plate-method diet
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. |
- Change in HbA1c [ Time Frame: 0 to 12 months ]HbA1c will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
- Change in Inflammation based on high sensitivity C-reactive protein (hsCRP) [ Time Frame: 0 to 12 months ]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.
- Change in small particle low-density lipoproteins (LDL) [ Time Frame: 0 to 12 months ]
- Change in high-density lipoproteins (HDL) [ Time Frame: 0 to 12 months ]
- Change in triglycerides [ Time Frame: 0 to 12 months ]
- Change in percent body weight loss [ Time Frame: 0 to 12 months ]
- Change in percent body fat on DEXA [ Time Frame: 0 to 12 months ]This will be measured by dual-energy X-ray absorptiometry scan
- Change in percent lean body mass on DEXA [ Time Frame: 0 to 12 months ]This will be measured by dual-energy X-ray absorptiometry scan
- Change in bone mineral density in total hip [ Time Frame: 0 to 12 months ]This will be measured by dual-energy X-ray absorptiometry scan
- Change in bone mineral density in lumbar spine [ Time Frame: 0 to 12 months ]This will be measured by dual-energy X-ray absorptiometry scan
- Change in serum procollagen type I N propeptide (s-PINP) [ Time Frame: 0 to 12 months ]
- Change in serum c-terminal telopeptide of type 1 collagen (s-CTX) [ Time Frame: 0 to 12 months ]
- Reduction in diabetes medications using medication effect score (MES) [ Time Frame: 0 to 12 months ]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).
- Change in HbA1c [ Time Frame: 0 to 4 months ]HbA1c will be measured by standard immunoturbidimetric assay methods and quality control measures at a Clinical Laboratory Improvement Amendments (CLIA) certified lab.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- diagnosis of type 2 diabetes, with current HbA1c > 6.5% and < 12% (self-reported and then measured at screening)
- ability to speak English (this is a group-based intervention)
- ability to engage in light physical activity
- willingness to be randomized to either type of diet
Exclusion Criteria:
- unable to provide informed consent
- substance abuse, mental health, cognitive, or medical condition that would, in the opinion of the investigators, make it difficult for the individual to take part in the intervention or may alter key outcomes or require important diet modifications
- pregnant or planning to become pregnant in the next 12 months, or currently breastfeeding (pregnancy and breastfeeding require modifications to the intervention's dietary approaches)
- current use of weight loss medications (this is likely to alter weight outcomes and may alter other measures)
- history of weight loss (bariatric) surgery or plans for bariatric surgery in the next year
- currently enrolled in a weight loss program or have unalterable plans to enroll in one of these programs in the next year
- vegan or vegetarian
- unwilling or unable to participate in study measurements and group classes
- current use of systemic steroids or immunomodulators (self-reported in screening survey; oral or IV systemic steroids excluded. Injected steroids may be permitted depending on frequency and timing of injections with regard to lab assessments (minimum of 2 weeks between injection and blood tests))
- weight above 400 pounds (weight limit for dual-energy X-ray absorptiometry (DEXA) scans)
- history of multiple or recent (within the last four years) kidney stones
- currently following a very low-carbohydrate diet
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05237128
| Contact: Laura Saslow, PhD | 734-764-7836 | legendstudy@med.umich.edu |
| United States, California | |
| The University of California San Francisco (UCSF) | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Patty Moran, PhD 415-353-9723 legendstudy@uscf.edu | |
| Principal Investigator: Rick Hecht, MD | |
| United States, Michigan | |
| University of MIchigan | Not yet recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Laura Saslow 734-764-7836 legendstudy@med.umich.edu | |
| Principal Investigator: Laura Saslow, PhD | |
| Principal Investigator: | Laura Saslow, PhD | University of Michigan |
| Responsible Party: | Laura Saslow, Assistant Professor, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT05237128 |
| Other Study ID Numbers: |
HUM00202808 R01DK126898-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | February 11, 2022 Key Record Dates |
| Last Update Posted: | May 24, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Very low-carbohydrate diet Moderate-carbohydrate plate-method diet Nutrition therapy |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |