SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05057806
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 25 MG — DRUG
    Empagliflozin 25MG will be administered orally once per day for 3 months
  • Placebo — DRUG
    The placebo will be administered orally once per day for 3 months

Study Details

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.

Key Dates

Start date
Jan 13, 2021
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Empagliflozin Group
    Subjects will be randomized 2:1 to receive empagliflozin, 25mg/day for 3 months
  • Placebo Comparator: Placebo group
    Subjects will be randomized to receive the empagliflozin placebo for 3 months

Primary Outcome Measure

Change in Phosphocreatine [ Time Frame: Baseline to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Carolina Solis-Herrera, MD
[email protected]
210-567-4800
Francisca M Acosta, PhD
[email protected]
210-450-8677
Carolina Solis-Herrera, MD (PRINCIPAL_INVESTIGATOR)

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