RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET

Quick Facts

Study Start:2024-11-20

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06510894

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Mary E Hansbury, BS

CONTACT

2157468192

mary.hansbury@pennmedicine.upenn.edu

Erin Schubert, BA

CONTACT

215-573-6569

erin.schubert@pennmedicine.upenn.edu

Principal Investigator

Paco Bravo, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Paco Bravo, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-20

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-11-20

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Cardiac Sarcoidosis