Effect of Tadalafil Administration on Vasodilatation Mediated by Flow in Patients With Obesity Grade I-II

Phase 3

• Conditions: Obesity and Erectile Dysfuntion
• Interventions: Drug: Tadalafil 20 MG

• Registration Number: NCT03905018
• Lead Sponsor: Centro Universitario de Ciencias de la Salud, Mexico

Brief Summary

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.

Detailed Description

: 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.

Study Timeline

• Study First Submitted: 2019-02-19
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-04
• Last Update Submitted: 2019-04-04
• Study First Posted: 2019-04-05
• Last Update Posted: 2019-04-05
• Study Start: 2019-05-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• Male patients
• Age 25 to 60 years
• Obesity grade I-II
• .Sign the inform consent form.
• Answer the questionary IIFE

Exclusion Criteria

. DM 1-2

• Systemic arterial hypertension
• Uncontrolled Mixed Dyslipidemia or under Hypolipemiant Treatment with statins.
• Active smoking
• Precedent of uncontrolled Ischemic cardiopathy.
• Use of anti-inflammatory drugs, including Acetylsalicylic acid, antihypertensive, antihyperglucemic, anti-anginal drugs, recent use of antiviral drugs that contains vasoconstrictors.
• Hepatic, renal, thyroid, and/or pulmonary decompensated disease.
• The precedent of hypersensibility to the phosphodiesterase-5 inhibitors.
• Patients that are under treatmen with iPDE

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tadalafil	Tadalafil 20 MG	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
calcined magnesia (placebo)	Tadalafil 20 MG	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 second will receive 20 mg of calcined magnesia (placebo),after a single administration

Primary Outcome Measures

Name	Time	Method
vasodilatation mediated by flow	24 hours	the effect of administration of tadalafil on vasodilatation mediated by flow with UNEXEF in patients with obesity grade I-II and erectil dysfunction. A double-blind clinical trial with randomization and control group will be carried out.

Secondary Outcome Measures

Name	Time	Method
International Index Erectile Function	24 hours	evaluate erectile funtion with a test (IIFE)

Trial Locations

Locations (1)

Fernando Grover Paez; 🇲🇽 Guadalajara, Jalisco, Mexico