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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus Type 2 Without Complication

Intervention / Treatment
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* Drug: Dapagliflozin 10Mg Tab
* Drug: Empagliflozin 25 MG
* Other: Placebo


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin 10 mg<br>Dapagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to a sodium-glucose cotransporter 2 (SGLT2) inhibitors. | Drug: Dapagliflozin 10Mg Tab<br>* Daily morning dose per oral of Dapagliflozin 10 mg for 7 days<br>* Other names: Farxiga, Forxiga;|
| Experimental: Empagliflozin 25 mg<br>Empagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors. | Drug: Empagliflozin 25 MG<br>* Daily morning dose per oral of Empagliflozine 25 mg for 7 days<br>* Other names: Jardiance;|
| Placebo Comparator: Placebo<br>Calcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder. | Other: Placebo<br>* Daily morning dose per oral of Calcined magnesite 500 mg for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |