Actively Recruiting
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-04-06
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
D
Doris Duke Charitable Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of SGLT2 inhibitors, specifically empagliflozin, on people with type 2 diabetes and heart failure with reduced ejection fraction. The study aims to understand how increased plasma ketones from this medication impact skeletal muscle and heart muscle ketone uptake, muscle energy production, exercise capacity, and patient-reported physical function and well-being. Participants will be randomly assigned to one of two groups: one receiving empagliflozin 25 mg orally once daily for 12 weeks, and the other receiving a placebo for the same duration. The study uses detailed muscle and heart imaging techniques to measure energy metabolites and exercise capacity, alongside questionnaires assessing physical function. During the study, participants will undergo muscle bioenergetic assessments using specialized magnetic resonance spectroscopy, cardiopulmonary function tests, and patient-reported outcome surveys. Researchers will measure changes in muscle energy compounds and exercise capacity over the 3-month treatment period to evaluate how empagliflozin affects heart and muscle function in this population.
CONDITIONS
Brief Title
SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Type 2 Diabetes Mellitus
- Class II-III New York Heart Association (NYHA) heart failure with reduced ejection fraction (EF) below 50%
- Age between 18 and 80 years
- Body mass index (BMI) between 23 and 38 kg/m2
- Glycated hemoglobin (HbA1c) between 5.5% and 10%
- Blood pressure less than or equal to 145/85 mmHg
- Estimated glomerular filtration rate (eGFR) at least 30 ml/min/1.73 m2
- Stable dose of guideline-directed medications for heart failure and diabetes
- Stable body weight within 4 pounds over the last 3 months
- No severe claustrophobia
- No contraindications for MRI such as metal implants or pacemakers
You will not qualify if you...
- Current treatment with an SGLT2 inhibitor, glucagon-like peptide-1 receptor agonist (GLP-1 RA), or pioglitazone
- Pregnancy, lactation, or plans to become pregnant
- Allergy or sensitivity to study drugs or ingredients
- History of cancer
- Current drug or alcohol use or dependence
- Inability or unwillingness to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive empagliflozin or placebo orally once per day to study its effects on muscle bioenergetics, cardiopulmonary function, and patient-reported outcomes.
Baseline visit and follow-up visits during the 12 weeks
Trial Site Locations
Total: 1 location
1
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
C
Carolina Solis-Herrera, MD
F
Francisca M Acosta, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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