Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression
Recruiting now
Conditions studied: Cardiac Sarcoidosis
In brief
This is a pilot mechanistic study of the diagnostic utility of sodium-glucose cotransporter-1/2 inhibition (SGLT1/2) on myocardial glucose suppression on FDG PET/CT. The investigators will test whether the addition of a SGLT1/2 inhibitor (SGLT1/2i) plus the standard dietary modification (ketogenic diet) will provide enhanced myocardial glucose suppression. The primary objective is to assess rates of complete myocardial glucose suppression (MGS) with 7 days of sotagliflozin 400 mg QD among healthy volunteers on a background of 1 day (N=20) or 3 days (N=20) of the KD. The secondary goal is to investigate the relationship between sotagliflozin, targeted metabolite levels, and myocardial glucose utilization on FDG-PET. Participants will be asked to: * undergo a screening visit that includes blood tests, vitals, and questions regarding health history/medications * take the provided sotagliflozin as instructed for 7 days leading up to the scan * follow a ketogenic diet as instructed for 1 or 3 days leading up to the scan * undergo an FDG PET/CT scan, which includes vitals and blood draws
Key facts
- Study ID
- NCT06510894
- Run by
- University of Pennsylvania
- People needed
- 40
- Starts
- 2024-11-20
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-01-07
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult patients, at least 18 years of age
- 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
- No history of chronic liver or kidney disease per medical record review and/or self-report.
- 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.
You may not qualify if…
- 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.
- Participants who are currently taking diuretics for any indication.
- Participants with an eGFR level <30 mL/min/1.73m2.
- Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
- 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.
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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