Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression
ConditionCardiac Sarcoidosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Pennsylvania
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sotagliflozin
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Pennsylvania
Lead sponsor
Duke University
Collaborator
Source ClinicalTrials.gov