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NCT06108076
Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes
EARLY_PHASE1 trial testing Ketone Monoester (KE) in Type 2 Diabetes in 10 participants. Currently enrolling.
31 July 2026
Quick facts
| Lead sponsor | The University of Texas Health Science Center at San Antonio |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 16 January 2024 |
| Primary completion | 31 July 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ketone Monoester (KE) — full drug profile →
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
- Heart Failure, Reduced Ejection Fraction — all drugs for Heart Failure, Reduced Ejection Fraction →
Sponsor
The University of Texas Health Science Center at San Antonio
Who can join
Adults 18 to 80, any sex, with Type 2 Diabetes or Heart Failure, Reduced Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will provide insight into whether cardiac function changes with oral Ketone Esters (KE) administered to patients with Type 2 Diabetes Mellitus (T2DM) and Heart failure with reduced ejection fraction (HFrEF). Plasma ketones are avidly extracted by cardiac muscle and their uptake is not dependent upon insulin or influenced by insulin resistance.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Advances in myocardial energy metabolism: metabolic remodelling in heart failure and beyond.
Sun Q, Karwi QG, Wong N, Lopaschuk GD. · · 2024 · cited 55× · PMID 39453987 · DOI 10.1093/cvr/cvae231
Verify or expand the search:
- PubMed search for NCT06108076
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ketone Monoester (KE)
Trials testing the same drug.
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT06715748 — Effects of Exogenous Ketones on Acute Changes and Recovery of the Heart Muscle After Intense Exercise. · Phase 4 · recruiting
- NCT06590623 — The Effect of Acute Exogenous Oral Ketone Supplementation on Immune Cells Function and Immune Cells Histone Β-hydroxybut · NA · recruiting
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
- NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- 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 The University of Texas Health Science Center at San Antonio trials
Trials by the same sponsor.
- NCT07280897 — SCIPI Implementation and Evaluation: A Multi-site Proof-of-Concept Pilot Trial · NA · not yet recruiting
- NCT07053319 — SGLT2i, Pioglitazone, and Ketone Production in T2D · Phase 1 · recruiting
- NCT07056699 — SGLT2i, Pioglitazone, and Ketone Production in T1D · Phase 3 · not yet recruiting
- NCT06609343 — Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis · Phase 1, PHASE2 · not yet recruiting
- NCT07437053 — Sarcopenia in Chronic Kidney Disease (CKD) Patients · EARLY_PHASE1 · not yet recruiting
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 NCT06108076 (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 The University of Texas Health Science Center at San Antonio
- Last refreshed: 21 January 2026
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/NCT06108076.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing