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

April 5, 2024 updated by: Matthieu Pelletier-Galarneau, MD MSc

Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
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.
Through study completion, up to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matthieu Pelletier-Galarneau, MD MSc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM 2024-3356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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