NCT03560323CompletedPhase 1
Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1
Ketones, Muscle Metabolism, and SGLT2 Inhibitors - Protocol 1.
Source: ClinicalTrials.gov · Last updated 29 Sept 2025
Brief summary (registry, in English)
To examine the effect of an increase in plasma beta-hydroxy-butyrate (B-OH-B) levels, spanning the physiologic and pharmacologic range (+0.5, +2.0, and +5.0 mmol/L), on: (i) parameters of left ventricular (LV) systolic and diastolic function utilizing cardiac magnetic resonance imaging (MRI) and (ii) myocardial glucose uptake using positron emission tomography (PET) with 18F-fluoro-2-deoxy-D-glucose in type 2 diabetic patients with Class II-III New York Heart Association (NYHA).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 4 Jun 2018
- Start date
- 7 Jan 2019
- Primary completion date
- 30 Aug 2024
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Heart failure, Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT03560323
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 41
- From 7 Jan 2019 to the primary completion date, 30 Aug 2024
- 2 sites 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
- Treatment with Glucagon-like peptide-1 receptor agonist (GLP-1 RA), Dipeptidyl peptidase-4 inhibitors (DPP4i), pioglitazone, SGLT2 inhibitor or insulin.
Other illness
- Contraindications for MRI include metal plates, parts, screws, shrapnel, pins in the body, or cardiac pacemaker.
- Any other condition that in the opinion of the investigator create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results.
Other
- Women who are pregnant or breastfeeding.
Who the study is looking for
- Type 2 diabetes.
- Class II-III New York Heart Association (NYHA) heart failure with ejection fraction less than 50 %.
- Age 18-80 years.
- BMI 23-38 kg/m2.
- HbA1c 6.0-9.0 %.
- Blood pressure \< 145/85 mmHg.
- eGFR \> 30 mL/min/1.73 m2.
- NT-proBNP ≥ 500 pg/mL (or ≥ 300 pg/mL if ejection fraction is less than 35 %).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Diabetes Institute - University Health System Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University of Texas Health Science Center San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.