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Daily Tadalafil on Body Fat and Lean Mass

NCT02554045 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-10-26

No results posted yet for this study

Summary

Data confirming a role for PDE5 in adipocyte biology in vitro have been recently reported. However, a better understanding of the complex role of PDE5 in fat metabolism and whole body homeostasis requires the use of transgenic animal models either lacking or overexpressing PDE5 in adipose tissue. This will clarify the role of PDE5 in adipose expansion and metabolism, and also in glucose homeostasis and vascular function in vivo. Analysis of expression and activity of PDE5 in different sites of human adipose tissue (i.e. visceral vs. subcutaneous), and also in different metabolic conditions (i.e. high-fat diet vs. low calorie intake) could reveal if PDE5 can be considered to be a reliable 'marker' of metabolic dysfunction of the adipocyte. Importantly, chronic treatment with the PDE5 inhibitor sildenafil in a mouse model of diet-induced insulin resistance caused a significant improvement in insulin sensitivity . Also, in humans chronic exposure to tadalafil confirmed an improvement of insulin sensitivity in men with erectile dysfunction. However, the efficacy of long-term treatment with PDE5i awaits demonstration in human metabolic diseases such as obesity and insulin resistance.

The primary purpose of the study is to investigate the effects of tadalafil taken once a day on body composition in men with sexual distress and/or erectile dysfunction.

Conditions

Interventions

DRUG

Tadalafil

Patients will take tadalafil 2.5 mg tablet every morning for 8 weeks and then withdraw tadalafil for 8 weeks

DRUG

Placebo

Patients will take placebo tablet every morning for 8 weeks and then withdraw placebo for 8 weeks

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Antonio Aversa, MD-PHD · University of Roma La Sapienza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-06-30
Completion
2015-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02554045 on ClinicalTrials.gov