NCT05057806RecruitingEarly phase 1
SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 15 Sept 2021
- Start date
- 13 Jan 2021
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Heart failure
- NCT number
- NCT05057806
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 30
- From 13 Jan 2021 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
- Current drug or alcohol use or dependence
Other illness
- Allergy/sensitivity to study drugs or their ingredients
- Cancer
Other
- Pregnancy, lactation or plans to become pregnant
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent
Who the study is looking for
- Type 2 Diabetes Mellitus
- Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50%
- Age 18-80 years
- BMI 23-38 kg/m2
- Glycated hemoglobin (HbA1c) 5.5-10%
- Blood Pressure (BP) ≤ 145/85 mmHg
- Estimated glomerular filtration rate (eGFR) ≥30 ml/min•1.73 m2
- Stable dose of guideline-directed medications for heart failure and Diabetes
- Stable body weight (±4 pounds) over the last 3 months
- Does not suffer from severe claustrophobia
- No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.