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

NCT ID: NCT05109949

Last Updated: 2021-11-19

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2022-08-01

Brief Summary

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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.

Detailed Description

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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

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Diabetes Mellitus Type 2 Without Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dapagliflozin 10 mg

Dapagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to a sodium-glucose cotransporter 2 (SGLT2) inhibitors.

Group Type EXPERIMENTAL

Dapagliflozin 10Mg Tab

Intervention Type DRUG

Daily morning dose per oral of Dapagliflozin 10 mg for 7 days

Empagliflozin 25 mg

Empagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors.

Group Type EXPERIMENTAL

Empagliflozin 25 MG

Intervention Type DRUG

Daily morning dose per oral of Empagliflozine 25 mg for 7 days

Placebo

Calcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Daily morning dose per oral of Calcined magnesite 500 mg for 7 days

Interventions

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Dapagliflozin 10Mg Tab

Daily morning dose per oral of Dapagliflozin 10 mg for 7 days

Intervention Type DRUG

Empagliflozin 25 MG

Daily morning dose per oral of Empagliflozine 25 mg for 7 days

Intervention Type DRUG

Placebo

Daily morning dose per oral of Calcined magnesite 500 mg for 7 days

Intervention Type OTHER

Other Intervention Names

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Farxiga, Forxiga Jardiance

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of T2DM
* HbA1c \> 7 y \< 10
* BMI 25 - 34.9 kg/m2
* Signature of consent under information

Exclusion Criteria

* Hypertension
* Treated with insulin and / or loop diuretics and thiazides
* T1DM
* Hypotension
* Any autoimmune disease
* Liver disease
* Women whitout birth control method
* Women taking oral birth control or under hormone replacement therapy
* Woman pregnant or breastfeeding
* Untreated thyroid disease
* Patients with a cardiovascular disease that contraindicates the use of this pharmacological class
* Glomerular filtration rate \<60ml/min (Cockcroft-Gault)
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Universitario de Ciencias de la Salud, Mexico

OTHER

Sponsor Role lead

Responsible Party

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Fernando Grover Paez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fernando Grover-Páez, PhD

Role: STUDY_DIRECTOR

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS

Locations

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Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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CUCS-INTEC-XOLOTL

Identifier Type: -

Identifier Source: org_study_id