A study of sarcoidosis; based on a combined investigation of 160 cases including 30 autopsies from The Johns Hopkins Hospital and Massachusetts General Hospital.
W T LONGCOPE, D G FREIMAN
https://pubmed.ncbi.nlm.nih.gov/14899212Actively Recruiting
All Genders
Healthy Volunteers
ID06510894
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET
Led by University of Pennsylvania · Updated on 2026-01-07
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
D
Duke University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether adding a sodium-glucose cotransporter-1/2 inhibitor (SGLT1/2i), specifically sotagliflozin, to a ketogenic diet can improve myocardial glucose suppression during FDG PET/CT scans. The study focuses on healthy adult volunteers and investigates if 7 days of sotagliflozin combined with 1 or 3 days of a ketogenic diet enhances the heart's glucose suppression, which is important for better imaging quality in cardiac sarcoidosis evaluation. The study also explores the relationship between sotagliflozin, metabolite levels, and heart glucose use. Participants will take sotagliflozin 400 mg once daily for about 7 days before undergoing the FDG PET/CT scan. They will follow a ketogenic diet for either 1 day or 3 days leading up to the scan, with overnight fasting before the imaging. The PET/CT scan uses a special tracer to measure glucose activity in the heart. The study includes two groups of 20 volunteers each, differing by the length of the ketogenic diet before the scan. Participants will track their medication and diet intake in diaries. During the study, participants will have blood tests, vital sign checks, and health history reviews at screening and on the scan day. Blood samples will be analyzed for various metabolic markers to understand how they relate to heart glucose suppression. The diet diary will be reviewed to assess adherence to the ketogenic diet. The main outcome measures include the rate of complete heart glucose suppression and myocardial glucose use. The total participation time covers screening, 7 to 10 days of medication and diet, and the scan visit.
CONDITIONS
Brief Title
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression
Who Can Participate
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Females who are pregnant or breast-feeding
- Female participants of child-bearing potential must have a urine pregnancy test during screening and prior to FDG injection
- Participants currently taking diuretics for any indication
- Participants with an eGFR level <30 mL/min/1.73m2
- Inability to tolerate imaging procedures as judged by the investigator or treating physician
- Any other medical or psychological condition that could compromise safety or successful study participation
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to assess eligibility and perform blood tests
Treatment
Duration - 7 to 10 days
Participants take sotagliflozin daily for 7 to 10 days while following a ketogenic diet for 1 to 3 days prior to the FDG PET/CT scan.
1 baseline visit and 1 FDG PET/CT scan visit
Diagnostic Evaluation
Duration - 1 day
Participants undergo an FDG PET/CT scan to evaluate myocardial glucose suppression and image quality after the treatment period.
1 visit (in-person) for FDG PET/CT imaging and blood sampling
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
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Research Team
M
Mary E Hansbury, BS
E
Erin Schubert, BA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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