Ketones, SGLT2, HFrEF

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT06229678
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 25 MG Oral Tablet — 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
  • Acipimox 250 Mg Oral Capsule — DRUG
    subjects will be started on acipimox 250mg every 6 hours for 8 days while on continued empagliflozin/placebo therapy. This will be added at the end of 3 months after they finished baseline studies

Study Details

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

Key Dates

Start date
Jan 25, 2024
Status verified
Feb 2026
Primary completion
Nov 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
71 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
Texas Diabetes Institute - University Health SystemSan AntonioTexas78207
Sivaram Neppala, MD
[email protected]
210-358-7200
Jemema Rajan, MD
[email protected]
210-358-7200
Ralph DeFronzo, MD (PRINCIPAL_INVESTIGATOR)
Sivaram Neppala, MD (SUB_INVESTIGATOR)
Jemema Rajan, MD (SUB_INVESTIGATOR)

Find similar trials in San Antonio, TX

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Texas Diabetes Institute - University Health System· San Antonio, TX

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