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RECRUITING
NCT06229678
EARLY_PHASE1

Ketones, SGLT2, HFrEF

Sponsor: The University of Texas Health Science Center at San Antonio

View on ClinicalTrials.gov

Summary

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

Official title: Ketones, Muscle Metabolism, and SGLT2 Inhibitors

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

71

Start Date

2024-01-25

Completion Date

2027-03-01

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DRUG

Empagliflozin 25 MG Oral Tablet

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

DRUG

Acipimox 250 Mg Oral Capsule

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

Locations (1)

Texas Diabetes Institute - University Health System

San Antonio, Texas, United States