Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging

Not Applicable

Not yet recruiting

• Conditions: Myocardial Suppression

• Registration Number: NCT06350903
• Lead Sponsor: Matthieu Pelletier-Galarneau, MD MSc

Brief Summary

The overall objective of this study is to assess if the empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies.

Detailed Description

The overall objective of this study is to assess if the SGLT2 inhibitor empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies. This study will evaluate if an acute administration of empagliflozin (tablets of 10 and/or 25 mg) combined with fasting can sufficiently increase the BHB levels, a proxy of myocardial FDG uptake.

Study Timeline

• Study First Submitted: 2024-03-18
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-05
• Study First Posted: 2024-04-08
• Last Update Posted: 2024-04-09
• Study Start: 2024-06
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Aged 18 to 70 years
2. Ability to follow the HFLC diet
3. Ability to provide informed consent

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Exclusion Criteria

1. Treated with SGLT2 inhibitors
2. History of hypersensitivity or allergy to empagliflozin
3. Hypotension with blood pressure <100/65 mmHg
4. Strict vegan
5. Pregnancy
6. Breastfeeding
7. Type I or type II diabetes
8. Renal failure with Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.72m2
9. Receiving steroids
10. History of diabetic ketoacidosis (DKA)
11. History of hypoglycemia
12. Any condition that, in the opinion of the investigator, could compromise the participation in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Levels of serum Beta-hydroxybutyrate (BHB) mmol/L	1 day	Average differences in serum levels of BHB measured following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet

Secondary Outcome Measures

Name	Time	Method
Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L	1 day	Proportion of participants with serum BHB \>0.5 mmol/L following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet.
Proportions of glycemia levels (mmol/L) <3.5 mmol/L	1 day	Proportion of participants with glycemia \<3.5 mmol/L following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet.
Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey.	Through study completion, up to 3 months.	Proportion of participants who preferred the empagliflozin to the HFLC diet as assessed by a dedicated survey.