RecruitingEarly Phase 1NCT05057806

SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors, Ketones, and Cardiovascular Benefit Research Plan


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

30 participants

Start Date

Jan 13, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how a class of diabetes medications called SGLT2 inhibitors (such as empagliflozin or dapagliflozin) benefit the heart in people with both type 2 diabetes and heart failure. Researchers believe the benefit may come from these drugs raising ketone levels in the blood, which the heart uses as an efficient fuel source. **You may be eligible if...** - You have type 2 diabetes and heart failure with reduced pumping function - You are aged 18–80 with a BMI between 23 and 38 - Your blood pressure is controlled (at or below 145/85) - Your kidney function is adequate (eGFR ≥ 30) - Your blood sugar (HbA1c) is between 5.5% and 10% - You have been on stable medications for at least 3 months **You may NOT be eligible if...** - You are already taking an SGLT2 inhibitor, GLP-1 receptor agonist, or pioglitazone - You are pregnant, breastfeeding, or planning to become pregnant - You have cancer or active drug/alcohol dependence - You have severe claustrophobia or cannot have an MRI (e.g., pacemaker, metal implants) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 25 MG

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

DRUGPlacebo

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


Locations(1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

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NCT05057806


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