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Completed

NCT Number: NCT05237128

The Lifestyle Education About Nutrition for Diabetes (Legend) Study

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of California San Francisco (UCSF), San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, may alter key outcomes, or may require important diet modifications and includes conditions such as hypercalcemia or thyroid dysfunction
  • 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 (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
  • unwilling to stop an SGLT2 inhibitor medication if the participant were to be randomized to the very low-carbohydrate diet

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Comparing Two Dietary Approaches for Type 2 Diabetes: The LEGEND (Lifestyle Education About Nutrition for Diabetes) Study

Acronym: LEGEND

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2022
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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