Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.

NCT ID: NCT02595684

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-11-30

Brief Summary

Obesity is a chronic disease of multifactorial etiology that develops from the interaction of the influence of nutritive , metabolic , cellular and molecular psychological factors.

Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile dysfunction, and recently approved for the treatment of pulmonary hypertension , it is innovative because of its longer life means, provides efficacy after 36 hours and the highest selectivity.

The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and insulin secretion in obese men.

The investigators hypothesis is that the administration of tadalafil improve the insulin sensitivity and insulin secretion in obese men.

Detailed Description

A randomized, double-blind, placebo-controlled clinical trial in 18 men aged between 30 and 50 years with obesity (BMI 30-39.9) according to the World Health Organization (WHO) criteria without treatment.

They will be assigned randomly in two groups of 9 patients, each to receive 5 mg of tadalafil or placebo every day at night during 28 days.

There will be evaluated Insulin secretion, both first phase of insulin secretion by Stumvoll Inex as well as Total Insulin Secretion by Area Under the Curve of glucose and insulin and Insulinogenic Index, and Insulin sensitivity by Matsuda index.

Waist circumference, glucose and insulin levels, lipid profile and blood pressure are going to be load will be evaluated before and after intervention in both groups.

Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. Will be considered statistical significance p ≤0.05.

This protocol was approved by a local Ethics Committee and written informed consent will be obtained from all volunteers.

Conditions

Obesity

Study Design

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

Study Groups

Tadalafil

Tadalafil capsules

Group Type: EXPERIMENTAL

Tadalafil

Intervention Type: DRUG

Tadalafil capsules: 5 mg, one per day, at night, during 28 days.

Placebo

Calcined magnesia capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Calcined magnesia capsules: one per day, at night, during 28 days.

Interventions

Tadalafil

Tadalafil capsules: 5 mg, one per day, at night, during 28 days.

Intervention Type: DRUG

Placebo

Calcined magnesia capsules: one per day, at night, during 28 days.

Intervention Type: DRUG

Other Intervention Names

Tadalafilo; Calcined magnesia

Eligibility Criteria

Inclusion Criteria

• Men
• Age: 30-50 years
• BMI: 30 to 39.9 kg/m²
• No Pharmacotherapy during the last 3 months
• Signature Consent under Information

Exclusion Criteria

• Cholesterol: ≥ 240 mg / dl
• Triglycerides: ≥ 400 mg / dl
• Fasting glucose: ≥ 126 mg / dl
• Diabetes mellitus.
• Hypertension
• Patients with renal, liver and / or thyroid disease
• Consumption of drugs with known effects on glucose or insulin metabolism.
• Use of cigar and / or drugs
• Hypersensitivity to tadalafil

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Manuel González Ortiz

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuel González-Ortíz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

Instituto de Terapéutica Experimental y Clínica

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

TADALAFIL-OB

Identifier Type: -

Identifier Source: org_study_id