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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myocardial Suppression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Fast + 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.

Intervention Type OTHER

Fast + 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes