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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06510894
Status
Recruiting
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Conditions

  • Cardiac Sarcoidosis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Nov 20, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Complete myocardial glucose suppression [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Mary E Hansbury
[email protected]
2157468192
Erin Schubert
[email protected]
Paco Bravo, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Pennsylvania· Philadelphia, PA

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