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Sotagliflozin to improve heart scans for cardiac sarcoidosis, tested in healthy volunteers

Tests sotagliflozin with a special diet in healthy volunteers before heart scans.

Key facts

Who runs it
University of Pennsylvania
Where
Philadelphia, United StatesSee the site
Trial code
Registry title
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression
Status
Recruiting
People taking part
40 people, planned
Started
20 Nov 2024
Expected to end
31 Dec 2027
Type of study
Observational
Treatments tested
  • Sotagliflozin
Record updated
7 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy adult volunteers. They take sotagliflozin for 7 days and follow a ketogenic diet before a heart FDG PET/CT scan.

Age
18 years and older
Sex
All sexes can join
Disease stage
No history of heart or blood vessel disease, high blood pressure, high cholesterol, diabetes, heart failure, heart surgery or heart rhythm problems. No long-term liver or kidney disease.
Earlier treatment
People who currently take diuretics (water pills) cannot join.
Biomarker or test result
eGFR (a kidney function test) must not be below 30 mL/min/1.73m2.

Main reasons for not taking part

  • Pregnant or breast-feeding women
  • Currently taking diuretics for any reason
  • eGFR below 30 mL/min/1.73m2
  • Unable to tolerate imaging scans
  • Other medical or psychological conditions that make taking part unsafe

This trial only enrols healthy participants. The registry sentence this rests on: 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 registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Participants with an eGFR level <30 mL/min/1.73m2
  • Inability to tolerate imaging procedures in the opinion of the investigator or treating physician

Where in United States

  • University of PennsylvaniaPhiladelphia, United StatesContact: Mary E HansburyTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The group in the trial

  • 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.

    Treatment: Sotagliflozin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET
Plain-language title
Sotagliflozin to improve heart scans for cardiac sarcoidosis, tested in healthy volunteersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
7 January 2026