CClinicalTrials.gg
CompletedNCT06350903SWEET-HEARTUpdated Sep 29, 2025

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

An interventional study of Fast + High-fat low-carbohydrate diet and Fast + Empagliflozin in Myocardial Suppression, sponsored by Matthieu Pelletier-Galarneau, MD MSc. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Matthieu Pelletier-Galarneau, MD MSc · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myocardial Suppression
03

In context

Lead sponsor

Matthieu Pelletier-Galarneau, MD MSc is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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.

07

Study locations

1 site
  • Montreal Heart Institute
    Montreal, Quebec H1T1C8, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06350903
Lead sponsor
Matthieu Pelletier-Galarneau, MD MSc
Responsible party
Matthieu Pelletier-Galarneau, MD MSc (Chief, division of nuclear medicine at Institut de cardiologie de Montreal, Montreal Heart Institute) — Sponsor-investigator
First posted
Apr 8, 2024
Start date
Jun 1, 2024
Primary completion
Nov 1, 2024
Completion
Nov 1, 2024
Last update
Sep 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion