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The Lifestyle Education About Nutrition for Diabetes (Legend) Study (LEGEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05237128
Recruitment Status : Recruiting
First Posted : February 11, 2022
Last Update Posted : May 24, 2022
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Laura Saslow, University of Michigan

Brief Summary:

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

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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

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Change in small particle low-density lipoproteins (LDL) [ Time Frame: 0 to 12 months ]
  3. Change in high-density lipoproteins (HDL) [ Time Frame: 0 to 12 months ]
  4. Change in triglycerides [ Time Frame: 0 to 12 months ]
  5. Change in percent body weight loss [ Time Frame: 0 to 12 months ]
  6. Change in percent body fat on DEXA [ Time Frame: 0 to 12 months ]
    This will be measured by dual-energy X-ray absorptiometry scan

  7. 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

  8. 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

  9. 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

  10. Change in serum procollagen type I N propeptide (s-PINP) [ Time Frame: 0 to 12 months ]
  11. Change in serum c-terminal telopeptide of type 1 collagen (s-CTX) [ Time Frame: 0 to 12 months ]
  12. 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).

  13. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Laura Saslow, PhD 734-764-7836 legendstudy@med.umich.edu

Locations
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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         
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Laura Saslow, PhD University of Michigan
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Saslow, University of Michigan:
Very low-carbohydrate diet
Moderate-carbohydrate plate-method diet
Nutrition therapy
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases