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Could a diabetes drug make heart inflammation easier to spot?

NCT ID NCT06510894

Diagnosis Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a drug called sotagliflozin, combined with a short ketogenic diet, can help suppress normal sugar use by the heart. This would make PET scans clearer for detecting inflammation caused by cardiac sarcoidosis. Forty healthy volunteers will take the drug for a week and follow a special diet for 1 or 3 days before a scan. The goal is to see if this approach improves image quality, not to treat any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sotagliflozin (a drug that blocks sugar absorption to help the heart use less glucose)
What this could lead to
If successful, this could lead to a better, more reliable way to detect heart inflammation using PET scans, improving diagnosis of cardiac sarcoidosis.
What could go wrong
This is a very early pilot study in only 40 healthy people, not patients. It tests imaging, not treatment, so it may not translate to real-world diagnostic improvements.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

40 evaluable healthy volunteers

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cardiac sarcoidosis sarcoidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac sarcoidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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