Completed

NCT Number: NCT06350903

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

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.

Completed

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Key information

Conditions

Myocardial Suppression

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
Pregnancy
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

Treatment and study plan

Fast + High-fat low-carbohydrate diet

Other

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 + Empagliflozin

Combination 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.

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

Time frame: 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

Time frame: 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.

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

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

Sponsors and collaborators

Lead sponsor

Matthieu Pelletier-Galarneau, MD MSc

Other

Registry information

Official study title

Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial FDG-PET Imaging

Acronym: SWEET-HEART

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Apr 8, 2024
Registry last updated: Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.