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SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

NCT05057806 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-06

No results posted yet for this study

Summary

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

Interventions

DRUG

Empagliflozin 25 MG

Empagliflozin 25MG will be administered orally once per day for 3 months

DRUG

Placebo

The placebo will be administered orally once per day for 3 months

Sponsors & Collaborators

  • Doris Duke Charitable Foundation

    collaborator OTHER

  • Max and Minnie Tomerlin Voelcker Fund

    collaborator UNKNOWN

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Carolina Solis-Herrera, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2026-11-30
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05057806 on ClinicalTrials.gov