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

Heart Failure With Preserved Ejection Fraction Type2 Diabetes

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

Inclusion Criteria11

Type 2 Diabetes Mellitus
Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50%
Age 18-80 years
BMI 23-38 kg/m2
Glycated hemoglobin (HbA1c) 5.5-10%
Blood Pressure (BP) ≤ 145/85 mmHg
Estimated glomerular filtration rate (eGFR) ≥30 ml/min•1.73 m2
Stable dose of guideline-directed medications for heart failure and Diabetes
Stable body weight (±4 pounds) over the last 3 months
Does not suffer from severe claustrophobia
No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)

Exclusion Criteria6

Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
Pregnancy, lactation or plans to become pregnant
Allergy/sensitivity to study drugs or their ingredients
Cancer
Current drug or alcohol use or dependence
Inability or unwillingness of individual or legal guardian/representative to give written informed consent