Clinical trial NCT02595684: Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.
Official title: Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Obesity
Tadalfil
Insulin secretion
Insulin sensitivity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 18
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fasting Glucose
timeFrame: Fasting glucose at Day 28
measure: Postprandial Glucose
timeFrame: Postprandial glucose at Day 28
measure: First Phase of Insulin Secretion
timeFrame: First phase of insulin secretion at Day 28
measure: Total Insulin Secretion
timeFrame: Total insulin secretion at Day 28
measure: Insulin Sensitivity
timeFrame: Insulin sensitivity at Day 28
measure: Area Under the Curve (AUC) Glucose
timeFrame: AUC at Day 28
measure: Area Under the Curve (AUC) Insulin
timeFrame: AUC at Day 28
Secondary outcomes:
measure: Body Weight
timeFrame: Body Weight at Day 28
measure: Body Mass Index
timeFrame: Body Mass Index at Day 28
measure: Waist Circumference
timeFrame: Waist circumference at Day 28
measure: Triglycerides
timeFrame: Triglycerides levels at Day 28
measure: Total Cholesterol
timeFrame: Total cholesterol levels at Day 28
measure: High Density Lipoprotein Cholesterol (HDL-c)
timeFrame: HDL-c levels at Day 28
measure: Low Density Lipoprotein Cholesterol (LDL-c)
timeFrame: LDL-c levels at Day 28
measure: Systolic Blood Pressure
timeFrame: Systolic Blood Pressure at Day 28
measure: Diastolic Blood Pressure
timeFrame: Diastolic Blood Pressure at Day 28
measure: Body Fat
timeFrame: Body fat at Day 28
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto de Terapéutica Experimental y Clínica
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Manuel González-Ortíz, PhD
role: PRINCIPAL_INVESTIGATOR
References: