SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Sep 15, 2021

Keywords

ClinConnect Summary

This clinical trial, called the SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan, is investigating how a specific type of medication (SGLT2 inhibitors) affects heart and muscle health in people with type 2 diabetes and heart failure. The researchers want to understand how this medication might increase certain substances in the blood called ketones, which could help improve how the heart and muscles use energy during physical activity. They will also look at how these changes impact overall patient well-being and exercise ability.

To participate in this study, individuals need to be between 18 and 80 years old, have type 2 diabetes, and have a specific type of heart failure that is not too severe. Other important criteria include having a stable weight and being on certain heart medications. Participants can expect to be closely monitored and will take the medication while undergoing various tests to see how their heart and muscles respond. This research could provide valuable insights into improving treatment for people with these conditions.

Gender

ALL

Eligibility criteria

• Inclusion 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 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 Criteria:
• • 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