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

Primary Purpose

Obesity and Erectile Dysfuntion

Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Tadalafil 20 MG
Sponsored by
Centro Universitario de Ciencias de la Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity and Erectile Dysfuntion

Eligibility Criteria

25 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Fernando Grover PaezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tadalafil

calcined magnesia (placebo)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

International Index Erectile Function
evaluate erectile funtion with a test (IIFE)

Full Information

First Posted
February 19, 2019
Last Updated
April 4, 2019
Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03905018
Brief Title
Effect of Tadalafil Administration on Vasodilatation Mediated by Flow in Patients With Obesity Grade I-II
Official Title
Acute and Subacute Effect of Tadalafil Administration on Vasodilatation Mediated by Flow in Patients With Obesity Grade I-ii and Erectil Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Anticipated)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario de Ciencias de la Salud, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity and Erectile Dysfuntion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
A double-blind clinical trial with randomization and control group
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tadalafil
Arm Type
Experimental
Arm Description
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
Arm Title
calcined magnesia (placebo)
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tadalafil 20 MG
Other Intervention Name(s)
tadalafil
Intervention Description
tadalafil 20 mg orally ,after a single administration
Primary Outcome Measure Information:
Title
vasodilatation mediated by flow
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
International Index Erectile Function
Description
evaluate erectile funtion with a test (IIFE)
Time Frame
24 hours

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
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
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Grover Páez, PhD
Phone
(33) 10585200
Ext
34215
Email
fgroverp@hotmail.com
Facility Information:
Facility Name
Fernando Grover Paez
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
fernando Grover, PhD
Phone
(33)10585200
Ext
34215
Email
fgroverp@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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