Actively Recruiting

Early Phase 1
Age: 18Years - 80Years
All Genders
NCT05057806

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

324 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

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.

CONDITIONS

Official Title

SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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) less than 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 (BP) less than or equal to 145/85 mmHg
  • Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73 m2
  • Stable dose of guideline-directed medications for heart failure and diabetes
  • Stable body weight within plus or minus 4 pounds over the last 3 months
  • No severe claustrophobia
  • No contraindications for MRI (no metal plates, screws, shrapnel, pins, or cardiac pacemaker)
Not Eligible

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 their ingredients
  • 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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

Loading map...

Research Team

C

Carolina Solis-Herrera, MD

CONTACT

F

Francisca M Acosta, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan | DecenTrialz