Using SGLT1/2 inhibitors to improve heart imaging in healthy volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot mechanistic study evaluates the diagnostic utility of sodium-glucose cotransporter-1/2 inhibition (SGLT1/2i) to enhance myocardial glucose suppression during FDG PET/CT scans. Participants will take sotagliflozin for 7 days while following a ketogenic diet for either 1 or 3 days before the scan. The study aims to assess the rates of complete myocardial glucose suppression and explore the relationship between sotagliflozin, metabolite levels, and myocardial glucose utilization. Up to 40 healthy volunteers will be enrolled to complete the PET/CT scan.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult patients, at least 18 years of age
2. 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
3. No history of chronic liver or kidney disease per medical record review and/or self-report.
4. 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:

1. 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.
2. Participants who are currently taking diuretics for any indication.
3. Participants with an eGFR level \<30 mL/min/1.73m2.
4. Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
5. 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's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Paco Bravo, MD — University of Pennsylvania
• Study coordinator: Mary E Hansbury, BS
• Email: mary.hansbury@pennmedicine.upenn.edu
• Phone: 2157468192

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.