Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510894
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Diagnostic Utility of SGLT12 Inhibition to Facilitate Myocardial Glucose Suppression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diagnostic Utility of SGLT12 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot mechanistic study of the diagnostic utility of sodium-glucose cotransporter-12 inhibition SGLT12 on myocardial glucose suppression on FDG PETCT The investigators will test whether the addition of a SGLT12 inhibitor SGLT12i 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 N20 or 3 days N20 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 historymedications
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 PETCT scan which includes vitals and blood draws
Participants will be asked to
undergo a screening visit that includes blood tests vitals and questions regarding health historymedications
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 PETCT scan which includes vitals and blood draws
Detailed Description:
The purpose of this mechanistic pilot study is to evaluate the effect on myocardial glucose suppression and therefore on image quality with the addition of a brief course of an FDA approved SGLT12 inhibitor prior to FDG PETCT scan FDG PETCT is a clinically utilized scan for diagnosis of cardiac sarcoidosis following the standard diet and fasting requirements this study will test the addition of the 7 days of sotagliflozin prior to the scan
Sotagliflozin INPEFA is a sodium-glucose cotransporter-2 inhibitor SGLT12i Sodium-glucose cotransporter-2 inhibitor that has been studied in humans and is FDA approved for reduce the risk of cardiovascular death hospitalization for heart failure and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus chronic kidney disease and other cardiovascular risk factors In this study the investigators will be using it off-label in healthy volunteers and will be using only a short course approximately 1 week of the drug prior to the FDG PETCT PET scan Off-label use is when an FDA approved drug is prescribed for a conditionuse other than that for which the drug has been officially approved Therefore the study will be utilizing sotagliflozin in way that it has yet to be approved for by the FDA
The investigators may enroll up to 40 fully evaluable healthy volunteers A fully evaluable subject must complete the PETCT scan Subjects who do not complete the PETCT scan will not be counted as fully evaluable however collected data may still be used in some secondary analyses The participants will be aged at least 18 years old After completing a screening visit and meeting study eligibility each participant will undergo an FDG PET scan after taking sotagliflozin for 7 up to 10 maximum days and following a ketogenic diet for either 1 day N20 prior to the scan with overnight fasting or 3 days N20 prior to the scan with overnight fasting Enrollment of the 20 participants undergoing 3 days of KD is dependent on sufficient funding and therefore initial efforts will be targeted toward enrolling participants in the 1 day of KD stratum Participants will be asked to track when they have taken the sotagliflozin in a provided diary
FDG PETCT imaging will be used to evaluate glycolytic activity in the heart using the FDA approved clinical Positron Emission Tomography PET radiotracer 18F Fluorodeoxyglucose FDG Imaging will be done on a dedicated whole-body PET scanner For each PET scan dynamic images over the body will be acquired from the time of injection to up to 60 minutes after injection of FDG Imaging data will be processed as per standard protocols The study will be performed under the regulatory approval of the Penn Institutional Review Board IRB
Participants will undergo an FDG PETCT after taking 7 up to 10 maximum days of oral sotagliflozin overlapping with 1 or 3 days of dietary modification standard ketogenic diet and overnight fasting prior to FDG injection
For all subjects the investigators may measure blood levels of BHB lipids basic metabolic panel complete blood counts HbA1c free fatty acid acylcarnitine glucose and insulin at screening some of these tests will be repeated on the day of the scan The investigators plan to use the Penn Metabolomics Core and Penn Diabetes Radioimmunoassay and Biomarkers Core for sample processing Since intravenous access will be obtained for administration of the tracer on the day of the PET scan a blood draw will be performed from this line Thereafter the investigators will perform comprehensive targeted metabolomic profiling from this peripheral blood so the study team can correlate myocardial suppression with other metabolic markers Most of the research testing will occur at later dates with stored samples The lab test results that may be entered in the medical record include BHB lipids basic metabolic panel complete blood counts and glucose Other experimental test results will not be provided to the subjects
Participants will be asked to follow a standard prescribed ketogenic diet and keep a diet diary during the KD prior to the FDG PET visit this diet matches the clinical SOC pre-scan preparation for sarcoidosis On the day of FDG-PET the diet diary will be collected and reviewed by an investigator The diet will also be reviewed usually at a later date by a CHPS nutritional specialist and information reported by the subject will be used to perform meal analysis and estimate grams of fat protein and carbohydrates
This is a single institution pilot mechanistic study of FDG PETCT to determine optimal method of myocardial glucose suppression Patients may participate in this study if they are greater than 18 years of age Subjects that may meet eligibility criteria will be approached about study participation regardless of race or ethnic background
Sotagliflozin INPEFA is a sodium-glucose cotransporter-2 inhibitor SGLT12i Sodium-glucose cotransporter-2 inhibitor that has been studied in humans and is FDA approved for reduce the risk of cardiovascular death hospitalization for heart failure and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus chronic kidney disease and other cardiovascular risk factors In this study the investigators will be using it off-label in healthy volunteers and will be using only a short course approximately 1 week of the drug prior to the FDG PETCT PET scan Off-label use is when an FDA approved drug is prescribed for a conditionuse other than that for which the drug has been officially approved Therefore the study will be utilizing sotagliflozin in way that it has yet to be approved for by the FDA
The investigators may enroll up to 40 fully evaluable healthy volunteers A fully evaluable subject must complete the PETCT scan Subjects who do not complete the PETCT scan will not be counted as fully evaluable however collected data may still be used in some secondary analyses The participants will be aged at least 18 years old After completing a screening visit and meeting study eligibility each participant will undergo an FDG PET scan after taking sotagliflozin for 7 up to 10 maximum days and following a ketogenic diet for either 1 day N20 prior to the scan with overnight fasting or 3 days N20 prior to the scan with overnight fasting Enrollment of the 20 participants undergoing 3 days of KD is dependent on sufficient funding and therefore initial efforts will be targeted toward enrolling participants in the 1 day of KD stratum Participants will be asked to track when they have taken the sotagliflozin in a provided diary
FDG PETCT imaging will be used to evaluate glycolytic activity in the heart using the FDA approved clinical Positron Emission Tomography PET radiotracer 18F Fluorodeoxyglucose FDG Imaging will be done on a dedicated whole-body PET scanner For each PET scan dynamic images over the body will be acquired from the time of injection to up to 60 minutes after injection of FDG Imaging data will be processed as per standard protocols The study will be performed under the regulatory approval of the Penn Institutional Review Board IRB
Participants will undergo an FDG PETCT after taking 7 up to 10 maximum days of oral sotagliflozin overlapping with 1 or 3 days of dietary modification standard ketogenic diet and overnight fasting prior to FDG injection
For all subjects the investigators may measure blood levels of BHB lipids basic metabolic panel complete blood counts HbA1c free fatty acid acylcarnitine glucose and insulin at screening some of these tests will be repeated on the day of the scan The investigators plan to use the Penn Metabolomics Core and Penn Diabetes Radioimmunoassay and Biomarkers Core for sample processing Since intravenous access will be obtained for administration of the tracer on the day of the PET scan a blood draw will be performed from this line Thereafter the investigators will perform comprehensive targeted metabolomic profiling from this peripheral blood so the study team can correlate myocardial suppression with other metabolic markers Most of the research testing will occur at later dates with stored samples The lab test results that may be entered in the medical record include BHB lipids basic metabolic panel complete blood counts and glucose Other experimental test results will not be provided to the subjects
Participants will be asked to follow a standard prescribed ketogenic diet and keep a diet diary during the KD prior to the FDG PET visit this diet matches the clinical SOC pre-scan preparation for sarcoidosis On the day of FDG-PET the diet diary will be collected and reviewed by an investigator The diet will also be reviewed usually at a later date by a CHPS nutritional specialist and information reported by the subject will be used to perform meal analysis and estimate grams of fat protein and carbohydrates
This is a single institution pilot mechanistic study of FDG PETCT to determine optimal method of myocardial glucose suppression Patients may participate in this study if they are greater than 18 years of age Subjects that may meet eligibility criteria will be approached about study participation regardless of race or ethnic background
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None