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

NCT ID: NCT03905018

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2019-09-01

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.

Conditions

Obesity and Erectile Dysfuntion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tadalafil

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

Group Type: EXPERIMENTAL

Tadalafil 20 MG

Intervention Type: DRUG

tadalafil 20 mg orally ,after a single administration

calcined magnesia (placebo)

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

Group Type: PLACEBO_COMPARATOR

Tadalafil 20 MG

Intervention Type: DRUG

tadalafil 20 mg orally ,after a single administration

Interventions

Tadalafil 20 MG

tadalafil 20 mg orally ,after a single administration

Intervention Type: DRUG

Other Intervention Names

tadalafil

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Universitario de Ciencias de la Salud, Mexico

OTHER

Sponsor Role: lead

Responsible Party

Fernando Grover Paez

Investigador principal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fernando Grover Paez

Guadalajara, Jalisco, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Fernando Grover Páez, PhD

Role: CONTACT

fgroverp@hotmail.com

(33) 10585200 ext. 34215

Facility Contacts

fernando Grover, PhD

Role: primary

fgroverp@hotmail.com

(33)10585200 ext. 34215

Other Identifiers

TDLF

Identifier Type: -

Identifier Source: org_study_id