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To date one of the main independent biomarkers of cardiovascular disease is the arterial stiffness parameters measured by carotid-femoral pulse wave velocity. It is known that SGLT2 inhibitors develop cardiac protection over long term administration, but there's not enough studies about acute effects in early administration.
Measure basal carotid-femoral Pulse Wave Velocity through a Pulse Pen tonometer by DiaTecne among basic physical examination, blood test, anthropometric and hemodynamic measurements; then administrate randomly dapagliflozin 10 mg, empagliflozin 25 mg or placebo for 7 days and then perform all of the measurements and blood test again.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin 10 mg | Experimental | Dapagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to a sodium-glucose cotransporter 2 (SGLT2) inhibitors. |
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| Empagliflozin 25 mg | Experimental | Empagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors. |
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| Placebo | Placebo Comparator | Calcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10Mg Tab | Drug | Daily morning dose per oral of Dapagliflozin 10 mg for 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Pulse wave velocity | Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting plasma glucose | Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit; in an automated clinical chemistry analysis equipment brand XL-100Erba | 7 days |
| Total cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Grover-Páez, PhD | Institute of Experimental and Clinical Therapeutics (INTEC), CUCS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| C570240 | empagliflozin |
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| Empagliflozin 25 MG | Drug | Daily morning dose per oral of Empagliflozine 25 mg for 7 days |
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| Placebo | Other | Daily morning dose per oral of Calcined magnesite 500 mg for 7 days |
|
Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit.
| 7 days |
| Triglycerides | Change from baseline, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit. | 7 days |
| High-density lipoprotein cholesterol | Change from baseline, using the BioSystems® Direct / Detergent HDL kit | 7 days |
| Low-density lipoprotein cholesterol | Change from baseline, using the BioSystems® Cholesterol Oxidase / Peroxidase kit | 7 days |
| Creatinine | Change from baseline, using the BioSystems® kit Modified Jaffe's no deproteinization | 7 days |
| Blood pressure | Change from baseline, using an OMRON calibrated electronic digital sphygmomanometer model HEM 907 XL. The patient will remain seated in a chair resting his back on the backrest, with a minimum rest of 5 minutes, The average of 3 measurements such as BP will be taken | 7 days |