Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial FDG-PET Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Levels of serum Beta-hydroxybutyrate (BHB) mmol/L
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 18 to 70 years
- •Ability to follow the HFLC diet
- •Ability to provide informed consent
Exclusion Criteria
- •Treated with SGLT2 inhibitors
- •History of hypersensitivity or allergy to empagliflozin
- •Hypotension with blood pressure <100/65 mmHg
- •Strict vegan
- •Breastfeeding
- •Type I or type II diabetes
- •Renal failure with Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.72m2
- •Receiving steroids
- •History of diabetic ketoacidosis (DKA)
- •History of hypoglycemia
- •Any condition that, in the opinion of the investigator, could compromise the participation in the study
Outcomes
Primary Outcomes
Levels of serum Beta-hydroxybutyrate (BHB) mmol/L
Time Frame: 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 Outcomes
- Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L(1 day)
- Proportions of glycemia levels (mmol/L) <3.5 mmol/L(1 day)
- Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey.(Through study completion, up to 3 months.)
Investigators
Matthieu Pelletier-Galarneau, MD MSc
Chief, division of nuclear medicine at Institut de cardiologie de Montreal
Montreal Heart Institute