Dapagliflozin vs Empagliflozin on Flow Mediated Dilation in Type 2 Diabetes Mellitus

• Status: Not yet recruiting
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Type 2 diabetes mellitus (T2DM) is a considered one of the main global health challenges; the vascular endothelium plays an important role in vascular dysfunction in DM; Hyperglycemia induced by it is recognized as the main factor for the development of vascular complications of the disease, secondary to a reduction in nitric oxide production; "flow-mediated dilation" is the most commonly used technique for the evaluation of endothelial function, being the non-invasive method most widely used. It has been reported that with the use of SGLT2 inhibitors the development of cardiovascular complications in patients with T2DM is a decrease, as well the arterial stiffness, endothelial dysfunction and increasing on the shear stress and blood viscosity; and experimentally.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Universitario de Ciencias de la Salud, Mexico
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin; Empagliflozin

Criteria

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

• With any autoimmune disease

• Liver disease

• Women who do not have a safe method of contraception

• Women who are taking oral contraceptives or under treatment with 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)