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

Matthieu Pelletier-Galarneau, MD MSc16 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Myocardial Suppression

Interventions

Fast + High-fat low-carbohydrate dietOTHER

Participants will be instructed to follow a strict HFLC diet starting on the morning of the day before the visit and to fast for 14 hours, starting at 7pm the day before the visit. Participants will be allowed to drink water and take their medications.

Fast + EmpagliflozinCOMBINATION_PRODUCT

Participants will be instructed to fast for 14 hours, starting at 7pm the day before the visit. Participants will be allowed to drink water and take their medications. Participants will also be instructed to take an oral dose of 50 mg of empagliflozin at 7am the morning before the experimental visit and on the day of the experimental visit.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Montreal Heart Institute

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Levels of serum Beta-hydroxybutyrate (BHB) mmol/L

Average differences in serum levels of BHB measured following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet

Time frame: 1 day

Secondary Outcomes

Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L

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.

Time frame: 1 day

Proportions of glycemia levels (mmol/L) <3.5 mmol/L

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.

Time frame: 1 day

Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey.

Proportion of participants who preferred the empagliflozin to the HFLC diet as assessed by a dedicated survey.

Time frame: Through study completion, up to 3 months.

Data from ClinicalTrials.gov

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