Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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.

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Mary E Hansbury, BS
mary.hansbury@pennmedicine.upenn.edu
2157468192
Backup
Erin Schubert, BA
erin.schubert@pennmedicine.upenn.edu
215-573-6569
Time Frame
Start Date: 2024-11-20
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 40
Treatments
Ketogenic Diet with sotagliflozin
40 volunteers will take a SGLT1/2i, sotagliflozin (400 mg QD), for 7 days prior to the PET scan visit and will undergo FDG PET/CT after 1-3 day of dietary modification (ketogenic diet for at least 3-9 meals) and overnight fasting prior to FDG injection.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania
Collaborators: Duke University

This content was sourced from clinicaltrials.gov

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