Type 2 DiabetesLEGENDNCT05237128
The Lifestyle Education About Nutrition for Diabetes (Legend) Study
A study testing Very low-carbohydrate diet and Moderate-carbohydrate plate-method diet in people with Type 2 Diabetes, run by University of Michigan at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Very low-carbohydrate diet and Moderate-carbohydrate plate-method diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2022to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of MIchigan
Ann Arbor, Michigan, 48109
The University of California San Francisco (UCSF)
San Francisco, California, 94143
About this study
Official title: Comparing Two Dietary Approaches for Type 2 Diabetes: The LEGEND (Lifestyle Education About Nutrition for Diabetes) 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Very low-carbohydrate diet, Moderate-carbohydrate plate-method diet
- Keywords
- Very low-carbohydrate diet, Moderate-carbohydrate plate-method diet, Nutrition therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low-carbohydrate dietBehavioural
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 dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Very low-carbohydrate diet | Experimental | Not described Receives: Behavioral: Very low-carbohydrate diet |
| Moderate-carbohydrate plate-method diet | Experimental | Not described Receives: Behavioral: Moderate-carbohydrate plate-method diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 12 months
Secondary outcomes (13)
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.
Measured: 0 to 12 months
Change in small particle low-density lipoproteins (LDL)
Measured: 0 to 12 months
Change in high-density lipoproteins (HDL)
Measured: 0 to 12 months
Change in triglycerides
Measured: 0 to 12 months
Change in percent body weight loss
Measured: 0 to 12 months
Change in percent body fat on DEXA
This will be measured by dual-energy X-ray absorptiometry scan
Measured: 0 to 12 months
Change in percent lean body mass on DEXA
This will be measured by dual-energy X-ray absorptiometry scan
Measured: 0 to 12 months
Change in bone mineral density in total hip
This will be measured by dual-energy X-ray absorptiometry scan
Measured: 0 to 12 months
Change in bone mineral density in lumbar spine
This will be measured by dual-energy X-ray absorptiometry scan
Measured: 0 to 12 months
Change in serum procollagen type I N propeptide (s-PINP)
Measured: 0 to 12 months
Change in serum c-terminal telopeptide of type 1 collagen (s-CTX)
Measured: 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).
Measured: 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.
Measured: 0 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start22 Mar 2022
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Saslow, University of Michigan
- Investigators
- Laura Saslow, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237128
- Sponsor's protocol ID
- HUM00202808
- Other IDs
- R01DK126898-01A1
- Acronym
- LEGEND
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37475033
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Dietary Approaches for Type 2 Diabetes: The LEGEND (Lifestyle Education About Nutrition for Diabetes) Study
- ClinicalTrials.gov ID
- NCT05237128
- Acronym / sponsor ID
- LEGEND / HUM00202808
- Conditions
- Type 2 Diabetes
- Keywords
- Very low-carbohydrate diet, Moderate-carbohydrate plate-method diet, Nutrition therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very low-carbohydrate diet | Experimental | Behavioral: Very low-carbohydrate diet |
| Moderate-carbohydrate plate-method diet | Experimental | Behavioral: Moderate-carbohydrate plate-method diet |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very low-carbohydrate dietParticipants 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. | Behavioural | Very low-carbohydrate diet |
| Moderate-carbohydrate plate-method dietParticipants 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. | Behavioural | Moderate-carbohydrate plate-method diet |
Primary outcome
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.
13 secondary outcomes
Change in Inflammation based on high sensitivity C-reactive protein (hsCRP)
Time frame: 0 to 12 months
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
Change in percent lean body mass on DEXA
Time frame: 0 to 12 months
Change in bone mineral density in total hip
Time frame: 0 to 12 months
Change in bone mineral density in lumbar spine
Time frame: 0 to 12 months
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
Change in HbA1c
Time frame: 0 to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 37475033Saslow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Saslow, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low-carbohydrate diet and Moderate-carbohydrate plate-method diet in people with Type 2 Diabetes, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 0 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.