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

NCT03905018 | Unknown Phase 3 DMC

• 1 other identifier: TDLF
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity and Erectile Dysfuntion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• International Index Erectile Function

  24 hours

Study Arms (2)

tadalafil

EXPERIMENTAL

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

calcined magnesia (placebo)

PLACEBO COMPARATOR

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

Interventions

Tadalafil 20 MG DRUG

tadalafil 20 mg orally ,after a single administration

Also known as: tadalafil

calcined magnesia (placebo); tadalafil

Eligibility Criteria

• Age: 25 Years - 60 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Fernando Grover Paez

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Fernando Grover Páez, PhD

CONTACT

(33) 10585200; fgroverp@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A double-blind clinical trial with randomization and control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador principal

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: April 5, 2019
• Study Start: May 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)