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

University of Pennsylvania · with Duke University · NCT06510894

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
40
US sites recruiting
1
Study start
November 20, 2024
Record last updated
January 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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

Being studied: Sotagliflozin

Conditions: Cardiac Sarcoidosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Recruiting US locations

  • University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Mary E Hansbury · 2157468192 · mary.hansbury@pennmedicine.upenn.edu

Study contacts (from the official record)

  • Mary E Hansbury, BS · 2157468192 · mary.hansbury@pennmedicine.upenn.edu
  • Erin Schubert, BA · 215-573-6569 · erin.schubert@pennmedicine.upenn.edu
All heart & blood pressure studies in Pennsylvania →
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial… (NCT06510894) | Bored Studies