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

NCT06350903 | Completed

• 1 other identifier: ICM 2024-3356
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Suppression

Outcome Measures

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

  1 day

Secondary Outcomes (3)

• 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.

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 70 years
• Ability to follow the HFLC diet
• Ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Matthieu Pelletier-Galarneau, MD MSc: lead

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

MeSH Terms

Interventions

empagliflozin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, division of nuclear medicine at Institut de cardiologie de Montreal

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 8, 2024
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 29, 2025

Record last verified: 2024-10

Locations

CA (1)