RECRUITING

SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-01-13
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05057806

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Type 2 Diabetes Mellitus
  2. * Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50%
  3. * Age 18-80 years
  4. * BMI 23-38 kg/m2
  5. * Glycated hemoglobin (HbA1c) 5.5-10%
  6. * Blood Pressure (BP) ≤ 145/85 mmHg
  7. * Estimated glomerular filtration rate (eGFR) ≥30 ml/min•1.73 m2
  8. * Stable dose of guideline-directed medications for heart failure
  9. * Stable body weight (±4 pounds) over the last 3 months
  1. * Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
  2. * Resting heart rate \>120 bpm
  3. * Systolic BP\>180mmHg and/or diastolic BP \>100mmHg
  4. * Resting percentage of blood oxygen saturation (SpO2) \< 85%
  5. * Physical disability preventing safe performance of the exercise protocol.

Contacts and Locations

Study Contact

Carolina Solis-Herrera, MD
CONTACT
210-567-4900
solisherrera@uthscsa.edu
Yuejuan Qin, PhD
CONTACT
210-358-7200
qiny@uthscsa.edu

Principal Investigator

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

Study Locations (Sites)

Texas Diabetes Institute - University Health System
San Antonio, Texas, 78207
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-13
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2021-01-13
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Ketones
  • Cardiovascular benefit

Additional Relevant MeSH Terms

  • Type2 Diabetes
  • Heart Failure With Preserved Ejection Fraction