Acute Effect of Dapagliflozin vs Empagliflozin Administration on Flow Mediated Dilation in Patients With Type 2 Diabetes Mellitus
Sponsor study identifier
interventional
24
1 country
1
Study Start
December 2, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 29, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 4, 2019
Actual (reported)December 11, 2019
Actual (reported)June 29, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Flow Mediated Dilation
Change from baseline Flow mediated dilation at 7 days. Using a high-resolution UNEX EF38G ultrasound®, in a room at 22°C, with the patient lying supine, and the right arm extended
7 days
Fasting plasma glucose
7 days
Total cholesterol
7 days
Triglycerides
7 days
High-density lipoprotein cholesterol
7 days
Low-density lipoprotein cholesterol
7 days
Individuals with T2DM controlled with metformin; with no hypertension neither treated with insulin. Dapagliflozin capsules, 10 mg 1 time daily 5 minutes before the first meal
Individuals with T2DM controlled with metformin; with no hypertension neither treated with insulin. Empagliflozin capsules, 25 mg 1 time daily 5 minutes before the first meal
Individuals with T2DM controlled with metformin; with no hypertension neither treated with insulin. Dapagliflozin capsules, 400 mg 1 time daily 5 minutes before the first meal
The patient will take one pill, every 24 hr, during 7 days
The patient will take one pill, every 24 hr, during 7 days
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340, Mexico
Fernando Grover Paez, PhD
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS
First Submitted
December 4, 2019
First Posted
December 11, 2019
Study Start
December 2, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
The patient will take one pill, every 24 hr, during 7 days
Contact the study team to confirm eligibility.
June 29, 2020
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 11, 2019
Record last verified: 2019-12
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