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

ConditionCardiac Sarcoidosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorUniversity of Pennsylvania

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

40 evaluable healthy volunteers

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Sotagliflozin
Drug
Sodium-glucose cotransporter-1/2 inhibitor

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Ketogenic Diet with sotagliflozin1 intervention

Trial outcomes

Primary outcomes

Complete myocardial glucose suppression

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

Time frame

7 days

Secondary outcomes

Myocardial glucose utilization

Myocardial glucose utilization in FDG PET/CT measured by SUV in the heart

Time frame

7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Duke University

Collaborator

Source ClinicalTrials.gov

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