ED
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
Sponsor study identifier
interventional
40
1 country
1
Study Start
January 30, 2019
Actual (reported)Primary Completion
December 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To evaluate the level of NGF,TrKA and p75NTR in patientd with erectile dysfunction and diabetes with or without metabolic syndrome
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2019
Actual (reported)February 14, 2019
Actual (reported)March 5, 2019
Actual (reported)December 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
plasmatic concentration verus intracavernous concetration
15 minutes
clinical staging of ED and NGF,TrKa,p75NTR
15 minutes
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Elisabetta Costantini
Terni, 05100, Italy
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.
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.
Ester Illiano, MD
University Of Perugia
First Submitted
February 14, 2019
First Posted
March 5, 2019
Study Start
January 30, 2019
Actual (reported)Primary Completion
December 30, 2019
Estimated (date passed)Baseline p75NTR
plasmatic concentration
baseline
plasmatic p75NTR
plasmatic concentration
15 minutes
intracavernous p75NTR
intracavernous concentration
15 minutes
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 5, 2019
Record last verified: 2019-01
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