Myocardial Suppression
Conditions
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.
Interventions
OTHERFast + High-fat low-carbohydrate diet
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.
COMBINATION_PRODUCTFast + Empagliflozin
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.
Sponsors
Matthieu Pelletier-Galarneau, MD MSc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed