Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression

Launched by UNIVERSITY OF PENNSYLVANIA · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help diagnose cardiac sarcoidosis, a condition that affects the heart. Researchers want to see if using a medication called sotagliflozin, along with a special diet called a ketogenic diet, can improve the ability to measure glucose usage in the heart using a type of scan called FDG PET/CT. The main goal is to find out if this combination helps completely suppress glucose in the heart, which could be useful for diagnosing this condition.

To be part of this study, participants need to be at least 18 years old and should not have any history of heart disease or chronic liver or kidney problems. Those interested will go through a screening process, take the medication for a week, follow the diet for 1 to 3 days, and then have the PET scan. It's important for everyone to understand that this is a research study, and they will need to give their consent to participate. The study is currently recruiting participants of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult patients, at least 18 years of age
• • 2. No history of cardiovascular disease, including hypertension, hyperlipidemia, diabetes mellitus, heart failure, coronary artery disease, cardiac surgery, arrhythmias per medical record review and/or self-report
• • 3. No history of chronic liver or kidney disease per medical record review and/or self-report.
• • 4. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
• Exclusion Criteria:
• • 1. Females who are pregnant or breast-feeding will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test during the screening visit and prior to FDG injection.
• • 2. Participants who are currently taking diuretics for any indication.
• • 3. Participants with an eGFR level \<30 mL/min/1.73m2.
• • 4. Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
• • 5. Any other medical or psychological condition that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.