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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity and Erectile Dysfuntion
• Intervention / Treatment: Drug: Tadalafil 20 MG

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Recruiting
      • Fernando Grover Paez
      • Contact: fernando Grover, PhD; Phone Number: 34215 (33)10585200; Email: fgroverp@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Tadalafil 20 MG; tadalafil 20 mg orally ,after a single administration; Other Names: tadalafil
Placebo Comparator: 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	Drug: Tadalafil 20 MG; tadalafil 20 mg orally ,after a single administration; Other Names: tadalafil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vasodilatation mediated by flow	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Index Erectile Function	evaluate erectile funtion with a test (IIFE)	24 hours

Collaborators and Investigators

• Sponsor: Centro Universitario de Ciencias de la Salud, Mexico

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: TDLF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No