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

Centro Universitario de Ciencias de la Salud, Mexico72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Diabetes Mellitus Type 2 Without Complication

Interventions

Dapagliflozin 10Mg TabDRUG

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

Empagliflozin 25 MGDRUG

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

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

Guadalajara, Jalisco, Mexico

Outcomes

Primary Outcomes

Pulse wave velocity

Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne.

Time frame: 7 days

Secondary Outcomes

Fasting plasma glucose

Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit; in an automated clinical chemistry analysis equipment brand XL-100Erba

Time frame: 7 days

Total cholesterol

Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit.

Time frame: 7 days

Triglycerides

Change from baseline, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit.

Time frame: 7 days

High-density lipoprotein cholesterol

Change from baseline, using the BioSystems® Direct / Detergent HDL kit

Time frame: 7 days

Low-density lipoprotein cholesterol

Change from baseline, using the BioSystems® Cholesterol Oxidase / Peroxidase kit

Time frame: 7 days

Creatinine

Change from baseline, using the BioSystems® kit Modified Jaffe's no deproteinization

Time frame: 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

Data from ClinicalTrials.gov

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