Recruiting

Sotagliflozin with Ketogenic Diet

Sponsor:

University of Pennsylvania

Code:

NCT06510894

Conditions

Cardiac Sarcoidosis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Sotagliflozin

Study Details

Brief 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

Conditions

Cardiac Sarcoidosis

Study ID

NCT06510894

Start date

Nov 20, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Sotagliflozin

Sodium-glucose cotransporter-1/2 inhibitor

Primary outcome measure

  • Complete myocardial glucose suppression [ Time Frame: 7 days ]

Central Contacts and Locations

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Paco Bravo, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • sarcoidosis
  • Cardiac Sacroidosis
  • SGLT1/2 Inhibition
  • Myocardial Glucose Suppression
  • Ketogenic Diet
  • sotagliflozin
  • Healthy volunteer
  • PET/CT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-01-07.