SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Description

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.

Conditions

Type2 Diabetes, Heart Failure With Preserved Ejection Fraction

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Study Overview

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Study Details

Study overview

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.

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

SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Condition
Type2 Diabetes
Intervention / Treatment

-

Contacts and Locations

San Antonio

Texas Diabetes Institute - University Health System, San Antonio, Texas, United States, 78207

San Antonio

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Stable body weight (±4 pounds) over the last 3 months
  • * Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
  • * Resting heart rate \>120 bpm
  • * Systolic BP\>180mmHg and/or diastolic BP \>100mmHg
  • * Resting percentage of blood oxygen saturation (SpO2) \< 85%
  • * Physical disability preventing safe performance of the exercise protocol.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center at San Antonio,

Carolina Solis-Herrera, MD, PRINCIPAL_INVESTIGATOR, University of Texas Health Science Center San Antonio

Study Record Dates

2027-03-31