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NCT05237128: LEGEND
The Lifestyle Education About Nutrition for Diabetes (Legend) Study
NA trial testing Very low-carbohydrate diet in Type 2 Diabetes in 182 participants. Completed in 1 October 2025.
1 October 2025
Quick facts
| Lead sponsor | University of Michigan |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 182 |
| Start date | 22 March 2022 |
| Primary completion | 1 October 2025 |
| Estimated completion | 1 October 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Very low-carbohydrate diet
- Moderate-carbohydrate plate-method diet
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
University of Michigan
Who can join
21 and older, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Saslow LR, Eslamian A, Moran P, Hartogensis W, et al · · 2023 · PMID 37475033 · DOI 10.1186/s13063-023-07512-9
Verify or expand the search:
- PubMed search for NCT05237128
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Very low-carbohydrate diet
Trials testing the same drug.
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- NCT05235425 — The Lifestyle Education About Prediabetes (Leap) Study · NA · completed
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
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- NCT07254689 — The Food for Health Study · NA · recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting
Other University of Michigan trials
Trials by the same sponsor.
- NCT07536919 — Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation · NA · not yet recruiting
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- NCT07471646 — Effects of Ramadan Fasting With Exercise on Cardiometabolic Health · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05237128 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Michigan
- Last refreshed: 10 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05237128.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing