NCT05109949

Acute Effect of Empagliflozin vs Dapagliflozin Over Pulse Wave Velocity in Type Two Diabetes

Acute Effect of Empagliflozin vs Dapagliflozin vs Placebo Administration Over Pulse Wave Velocity in Patients With Type Two Diabetes

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Centro Universitario de Ciencias de la Salud, Mexico · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus Type 2 Without Complication

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10Mg Tab	Daily morning dose per oral of Dapagliflozin 10 mg for 7 days
DRUG	Empagliflozin 25 MG	Daily morning dose per oral of Empagliflozine 25 mg for 7 days
OTHER	Placebo	Daily morning dose per oral of Calcined magnesite 500 mg for 7 days

Timeline

• Start date: 2020-03-30
• Primary completion: 2022-06-01
• Completion: 2022-08-01
• First posted: 2021-11-05
• Last updated: 2021-11-19

Locations

1 site across 1 country: Mexico