Obesity and Erectile Dysfuntion Clinical Trial
Official title:
Acute and Subacute Effect of Tadalafil Administration on Vasodilatation Mediated by Flow in Patients With Obesity Grade I-ii and Erectil Dysfunction
Obesity is a public health problem, not only for its high prevalence, but also because of the
comorbidities found in it. Within the physiopathological mechanisms associated with obesity
is a low-grade inflammatory state that is associated with endothelial dysfunction Endothelial
dysfunction is known to be the beginning of the atherosclerotic process that eventually leads
to the development of cardiovascular disease.
Erectile dysfunction is an example of endothelial dysfunction, where blood flow is
compromised as a consequence of a reduction in the production of nitric oxide among others.
Tadalafil, which is an inhibitor of PDE-5, is currently used as a treatment for erectile
dysfunction. However, it has been observed that the administration of tadalafil in patients
with éndothelial dysfunction decreases arterial stiffness, having a positive effect on it, in
addition it reduces the pulse pressure, systolic and diastolic pressure.
: The objective is to evaluate the effect of administration of tadalafil on vasodilatation
mediated by flow in patients with obesity grade I-II and erectil dysfunction. A double-blind
clinical trial with randomization and control group will be carried out. Male patients aged
25-60 years, BMI ≥30, without comorbidities will be included. They should not be under
treatment with iPDE5 or statins, nor should they have uncontrolled ischemic heart disease. To
carry out this test, two groups will be created: the first will receive a single dose of
tadalafil 20 mg orally and the second will receive 20 mg of calcined magnesia (placebo),after
a single administration, 24 hours later the investigators are going to evaluate
vasodilatation mediated by. In addition, they will have a metabolic profile at the beginning.
For the analysis of results the statistical program SPSS version 21 for Windows will be used.
The results will be expressed in averages and standard deviation and normality tests will be
applied such as Kolmogorov Smirnof, Shapiro Wilk, as well as the Willcoxon and U Mann Whitney
test.
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