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

NCT06510894 | Recruiting FDA Drug

• 1 other identifier: 855451
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Complete myocardial glucose suppression

  Rate of complete myocardial glucose suppression after 7-day regimen of sotagliflozin

  7 days

Secondary Outcomes (1)

• Myocardial glucose utilization

  7 days

Study Arms (1)

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.

Drug: Sotagliflozin

Interventions

Sotagliflozin DRUG

Sodium-glucose cotransporter-1/2 inhibitor

Also known as: INPEFA

Ketogenic Diet with sotagliflozin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 evaluable healthy volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Duke University: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (17)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples taken at two timepoints.

MeSH Terms

Conditions

Sarcoidosis

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Paco Bravo, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary E Hansbury, BS

CONTACT

2157468192; mary.hansbury@pennmedicine.upenn.edu

Erin Schubert, BA

CONTACT

215-573-6569; erin.schubert@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology and Medicine; Divisions of Nuclear Medicine, Cardiothoracic Imaging and Cardiovascular Medicine; Director, Nuclear Cardiology and Cardiovascular Molecular Imaging

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)