NCT03862547

Brief Summary

To evaluate the level of NGF,TrKA and p75NTR in patientd with erectile dysfunction and diabetes with or without metabolic syndrome

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

March 5, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

February 14, 2019

Last Update Submit

March 2, 2019

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionNGFTrKAp75NTR

Outcome Measures

Primary Outcomes (9)

  • Baseline NGF

    plasmatic concentration

    baseline

  • intracavernous NGF

    intracavernous concetration

    15 minutes

  • plasmatic NGF

    plasmatic concetration

    15 minutes

  • Baseline TRka

    plasmatic concetration

    baseline

  • plasmatic TRka

    plasmatic concetration

    15 minutes

  • Intracavernous TRka

    intracavernous concetration

    15 minutes

  • Baseline p75NTR

    plasmatic concentration

    baseline

  • plasmatic p75NTR

    plasmatic concentration

    15 minutes

  • intracavernous p75NTR

    intracavernous concentration

    15 minutes

Secondary Outcomes (2)

  • plasmatic concentration verus intracavernous concetration

    15 minutes

  • clinical staging of ED and NGF,TrKa,p75NTR

    15 minutes

Study Arms (1)

Men with ED and diabetes

EXPERIMENTAL

A peripheral blood sample from the cubital vein 1. A collection of peripheral blood from the routinary cubital vein for hormone dosage and metabolic evaluation 2. An introverted cavernous infiltration of Prostaglandin E1 to achieve erection (Aprostadil); 3. A blood sample from both the corpus cavernosum and the cubital vein, once the erection is achieved Baseline interaction of prostaglandin E1 on the concentration of NGF released in the medium and on the expression of its receptors Evaluation of NGF and Cytokine levels Expression analysis of TrKA and p75NTR receptors and intracellular cytokines in PBMCs

Diagnostic Test: A peripheral blood sample from the cubital vein

Interventions

A peripheral blood sample from the cubital veinDIAGNOSTIC_TEST

Evaluation of NGF and Cytokine levels A portion of each blood sample and medium conditioned by PBMC will be used for the enzyme immunoassay of NGF and pro and anti-inflammatory cytokine levels (TNF alfa and IL-10). Expression analysis of TrKA and p75NTR receptors and intracellular cytokines in PBMCs The remaining part of each blood sample and PBMC of the in vitro experiment will be used for the cytofluorimetric evaluation of the expression of TrKA, p75NTR and the pro and anti-inflammatory cytokines and reactive oxygen species.

Also known as: cavernous infiltration of PGE1
Men with ED and diabetes

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmen with erectile dysfunction and metabolic syndrome
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men with DE and metabolic syndrome

You may not qualify if:

  • men with DE without metabolic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elisabetta Costantini

Terni, 05100, Italy

RECRUITING

Related Publications (9)

  • Teng KK, Hempstead BL. Neurotrophins and their receptors: signaling trios in complex biological systems. Cell Mol Life Sci. 2004 Jan;61(1):35-48. doi: 10.1007/s00018-003-3099-3.

    PMID: 14704852BACKGROUND

  • Arcidiacono P, Stabile AM, Ragonese F, Pistilli A, Calvieri S, Bottoni U, Crisanti A, Spaccapelo R, Rende M. Anticarcinogenic activities of sulforaphane are influenced by Nerve Growth Factor in human melanoma A375 cells. Food Chem Toxicol. 2018 Mar;113:154-161. doi: 10.1016/j.fct.2018.01.051. Epub 2018 Jan 31.

    PMID: 29407470BACKGROUND

  • Pistilli A, Rende M, Crispoltoni L, Montagnoli C, Stabile AM. LY294002 induces in vitro apoptosis and overexpression of p75NTR in human uterine leiomyosarcoma HTB 114 cells. Growth Factors. 2015;33(5-6):376-83. doi: 10.3109/08977194.2015.1118096. Epub 2015 Dec 10.

    PMID: 26653825BACKGROUND

  • Pula G, Pistilli A, Montagnoli C, Stabile AM, Rambotti MG, Rende M. The tricyclic antidepressant amitriptyline is cytotoxic to HTB114 human leiomyosarcoma and induces p75(NTR)-dependent apoptosis. Anticancer Drugs. 2013 Oct;24(9):899-910. doi: 10.1097/CAD.0b013e328364312f.

    PMID: 23872911BACKGROUND

  • Rende M, Pistilli A, Stabile AM, Terenzi A, Cattaneo A, Ugolini G, Sanna P. Role of nerve growth factor and its receptors in non-nervous cancer growth: efficacy of a tyrosine kinase inhibitor (AG879) and neutralizing antibodies antityrosine kinase receptor A and antinerve growth factor: an in-vitro and in-vivo study. Anticancer Drugs. 2006 Sep;17(8):929-41. doi: 10.1097/01.cad.0000224459.13651.fd.

    PMID: 16940803BACKGROUND

  • Rask-Madsen C, King GL. Mechanisms of Disease: endothelial dysfunction in insulin resistance and diabetes. Nat Clin Pract Endocrinol Metab. 2007 Jan;3(1):46-56. doi: 10.1038/ncpendmet0366.

    PMID: 17179929BACKGROUND

  • Jackson G. The importance of risk factor reduction in erectile dysfunction. Curr Urol Rep. 2007 Nov;8(6):463-6. doi: 10.1007/s11934-007-0049-x.

    PMID: 18042325BACKGROUND

  • Kaya E, Sikka SC, Gur S. A comprehensive review of metabolic syndrome affecting erectile dysfunction. J Sex Med. 2015 Apr;12(4):856-75. doi: 10.1111/jsm.12828. Epub 2015 Feb 11.

    PMID: 25675988BACKGROUND

  • Dai YT, Chen Y, Yao LS, Yang R, Sun ZY, Wen DG. [Expression of nerve growth factor in cavernous tissue and its effects on the treatment of rats with diabetic erectile dysfunction]. Zhonghua Nan Ke Xue. 2005 Oct;11(10):748-51, 754. Chinese.

    PMID: 16281507BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Ester Illiano, MD

    University Of Perugia

    STUDY DIRECTOR

Central Study Contacts

Elisabetta Costantini, Professor

CONTACT

3283620614elisabetta.costantini@unipg.it

Ester Illiano, MD

CONTACT

3283620614ester.illiano@inwind.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor,MD

Study Record Dates

First Submitted

February 14, 2019

First Posted

March 5, 2019

Study Start

January 30, 2019

Primary Completion

December 30, 2019

Study Completion

January 30, 2020

Last Updated

March 5, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)