Using SGLT1/2 inhibitors to improve heart imaging in healthy volunteers
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET
University of Pennsylvania · NCT06510894
This study is testing whether a new diabetes medication can help improve heart imaging in healthy volunteers by better controlling how the heart uses sugar during scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06510894 on ClinicalTrials.gov |
What this trial studies
This pilot mechanistic study evaluates the diagnostic utility of sodium-glucose cotransporter-1/2 inhibition (SGLT1/2i) to enhance myocardial glucose suppression during FDG PET/CT scans. Participants will take sotagliflozin for 7 days while following a ketogenic diet for either 1 or 3 days before the scan. The study aims to assess the rates of complete myocardial glucose suppression and explore the relationship between sotagliflozin, metabolite levels, and myocardial glucose utilization. Up to 40 healthy volunteers will be enrolled to complete the PET/CT scan.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older with no history of cardiovascular or chronic liver/kidney diseases.
Not a fit: Patients with existing cardiovascular conditions or those currently taking diuretics will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the accuracy of diagnosing cardiac sarcoidosis through enhanced imaging techniques.
How similar studies have performed: While this approach is novel in the context of cardiac sarcoidosis, similar studies using SGLT inhibitors have shown promise in other cardiovascular contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Paco Bravo, MD — University of Pennsylvania
- Study coordinator: Mary E Hansbury, BS
- Email: mary.hansbury@pennmedicine.upenn.edu
- Phone: 2157468192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Sarcoidosis, sarcoidosis, Cardiac Sacroidosis, SGLT1/2 Inhibition, Myocardial Glucose Suppression, Ketogenic Diet, sotagliflozin, Healthy volunteer