Actively Recruiting
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression
Led by University of Pennsylvania · Updated on 2026-01-07
40
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
D
Duke University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 prior to study-specific procedures
You will not qualify if you...
- Females who are pregnant or breast-feeding
- Female participants of child-bearing potential must have a urine pregnancy test during screening and prior to FDG injection
- Participants currently taking diuretics for any indication
- Participants with an eGFR level <30 mL/min/1.73m2
- Inability to tolerate imaging procedures as per investigator or treating physician
- Any medical or psychological condition that would compromise safety or successful participation
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Mary E Hansbury, BS
CONTACT
E
Erin Schubert, BA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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