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Trial record 22 of 62 for:    Recruiting, Not yet recruiting, Available Studies | Impotence

NGF, TrKA,p75NTR in Men With ED and Diabetes With or Without MS (ED)

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ClinicalTrials.gov Identifier: NCT03862547
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
Ester Illiano, MD
Mario Rende,Full Professor
Alessandra Psitilli, Researcher
Anna Stabile, Researcher
Information provided by (Responsible Party):
Elisabetta Costantini, University Of Perugia

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

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Diagnostic Test: A peripheral blood sample from the cubital vein Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Role and Clinical Relevance of Nerve Growth Factor (NGF) and Its Receptors (TrKA and p75NTR) in Patients With Erectile Dysfunction and Diabetes With or Wothout Metabolic Syndrome
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Men with ED and diabetes

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

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.

Other Name: cavernous infiltration of PGE1




Primary Outcome Measures :
  1. Baseline NGF [ Time Frame: baseline ]
    plasmatic concentration

  2. intracavernous NGF [ Time Frame: 15 minutes ]
    intracavernous concetration

  3. plasmatic NGF [ Time Frame: 15 minutes ]
    plasmatic concetration

  4. Baseline TRka [ Time Frame: baseline ]
    plasmatic concetration

  5. plasmatic TRka [ Time Frame: 15 minutes ]
    plasmatic concetration

  6. Intracavernous TRka [ Time Frame: 15 minutes ]
    intracavernous concetration

  7. Baseline p75NTR [ Time Frame: baseline ]
    plasmatic concentration

  8. plasmatic p75NTR [ Time Frame: 15 minutes ]
    plasmatic concentration

  9. intracavernous p75NTR [ Time Frame: 15 minutes ]
    intracavernous concentration


Secondary Outcome Measures :
  1. plasmatic concentration verus intracavernous concetration [ Time Frame: 15 minutes ]
    to evaluate any differences between the data obtained from the systemic levy versus the intracavernous sampling.

  2. clinical staging of ED and NGF,TrKa,p75NTR [ Time Frame: 15 minutes ]
    is to evaluate if the levels of NGF and its receptors in the mononuclear cells can correlate with the clinical staging of ED.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   men with erectile dysfunction and metabolic syndrome
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men with DE and metabolic syndrome

Exclusion Criteria:

  • men with DE without metabolic syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862547


Contacts
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Contact: Elisabetta Costantini, Professor 3283620614 elisabetta.costantini@unipg.it
Contact: Ester Illiano, MD 3283620614 ester.illiano@inwind.it

Locations
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Italy
Elisabetta Costantini Recruiting
Terni, Italy, 05100
Contact: Elisabetta Costantini, Professor    3283620614    elisabetta.costantini@unipg.it   
Contact: Ester Illiano, MD    3283620614    ester.illiano@inwind.it   
Sub-Investigator: Ester Illiano, MD         
Principal Investigator: Elisabetta Costantini, Professor         
Sub-Investigator: Mario Rende, Professor         
Sub-Investigator: Alessandra Pistilli, Researcher         
Sub-Investigator: Anna Stabile, Researcher         
Sponsors and Collaborators
University Of Perugia
Ester Illiano, MD
Mario Rende,Full Professor
Alessandra Psitilli, Researcher
Anna Stabile, Researcher
Investigators
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Study Director: Ester Illiano, MD University Of Perugia

Publications:

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Responsible Party: Elisabetta Costantini, Associate Professor,MD, University Of Perugia
ClinicalTrials.gov Identifier: NCT03862547     History of Changes
Other Study ID Numbers: DE1
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elisabetta Costantini, University Of Perugia:
Erectile Dysfunction
NGF
TrKA
p75NTR

Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders