Actively Recruiting
Ketones, SGLT2, HFrEF
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-02-05
71
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function
CONDITIONS
Official Title
Ketones, SGLT2, HFrEF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes mellitus
- Classified as Class II-III New York Heart Association (NYHA) heart failure with reduced ejection fraction (EF) less than 50%
- Age between 18 and 80 years
- Body mass index (BMI) between 23 and 44 kg/m2
- Glycated hemoglobin (HbA1c) between 6.0% and 10.0%
- Blood pressure less than or equal to 145/85 mmHg
- Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73 m2
- Currently treated with diet/exercise, metformin, sulfonylureas, metformin/sulfonylurea combination, GLP-1 receptor agonist, or insulin
- Stable body weight within plus or minus 4 pounds over the previous 3 months
- Able to understand and comply with study procedures for the entire study duration
You will not qualify if you...
- Heart failure caused by restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, or hypertrophic obstructive cardiomyopathy
- Significant change in diuretic treatment during the month before screening (such as doubling dose or adding another heart failure medication)
- Treatment with Dipeptidyl Peptidase-4 Inhibitors (DPP4i) or pioglitazone for type 2 diabetes
- Pregnancy, breastfeeding, or planning to become pregnant; willingness to use contraception if of childbearing age
- Allergy or sensitivity to study drugs or their ingredients
- History of cancer
- Current drug or alcohol use or dependence interfering with study adherence
- Unable or unwilling to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Texas Diabetes Institute - University Health System
San Antonio, Texas, United States, 78207
Actively Recruiting
Research Team
R
Ralph DeFronzo, MD
CONTACT
S
Sivaram Neppala, MD
CONTACT
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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