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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Proportions of glycemia levels (mmol/L) <3.5 mmol/L |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Quebec | H1T1C8 | Canada |
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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. | Proportion of participants who preferred the empagliflozin to the HFLC diet as assessed by a dedicated survey. | Through study completion, up to 3 months. |
| ID | Term |
|---|---|
| C570240 | empagliflozin |
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