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

University of Guadalajara

Status and phase: Completed; Phase 4

Conditions: Obesity

Treatments: Drug: Tadalafil; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02595684

TADALAFIL-OB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Male

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Tadalafil

Experimental group

Description:

Tadalafil capsules

Treatment:

Drug: Tadalafil

Placebo

Placebo Comparator group

Description:

Calcined magnesia capsules

Treatment:

Drug: Placebo