Ignite Creation Date:
2024-05-06 @ 2:33 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04352712
Status:
UNKNOWN
Last Update Posted:
2020-05-14
First Post:
2020-04-15
Brief Title:
Gene Expression in Monocytes of Growth Hormone Deficient Children
Sponsor:
University of Salerno
Organization:
University of Salerno
Study Overview
Official Title:
Growth Hormone Modulated Gene Expression in Monocytes of Healthy and Growth Hormone Deficient Children
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEMGH
Brief Summary:
The Growth hormone GH is mainly synthesized in the anterior portion of the pituitary gland and has an effect on different body areas Secreted in the circulatory stream growth hormone reaches the liver and here stimulates the secretion of somatomedin C better known as insulin-like growth factor 1 IGF which constitutes its main anabolic effector
Growth hormone deficiency GHD is characterized by a delay in the statural growth in children and is correlated with a worsening of body composition cognitive functions lipid metabolism bone mineralization cardiac performance and exercise in adults Recombinant GH rhGH replacement therapy can correct these alterations and therefore improve the quality of life in treated patients and accelerate growth in children
The optimal dosage of rhGH varies for each patient as the response to treatment suffers from considerable inter-individual variability To date IGF1 is the only available biomarker whose plasma levels correlate with replacement therapy
It is important to underline how somatomedin C does not provide information about the optimal posology of rhGH for each patient in order therefore to predict its adverse events and efficacy
In addition it has been shown that the effects mediated by the somatotropic hormone on some tissues are direct therefore independent of the action of IGF1 whose plasma levels are not in this case predictive of therapeutic response
For this reason it is therefore necessary to identify a more specific biomarker capable of monitoring the efficacy individual responsiveness and any adverse events in patients receiving somatotropic hormone
The GH receptor GHR is expressed in several cells including monocytes It is therefore possible that the response of monocytes to the somatotropic hormone partially mirrors that of the chondrocyte and other cell types Given the difficulty of obtaining osteomuscular biopsies or specific body areas in which GH mediates its biological action the published works have identified the specific cell line in which to study the molecular effects of the hormone in monocytes thanks to their easy accessibility and high number of GHR
In consideration of this the investigators propose to stimulate monocytes of healthy and GHD children in vitro with rhGH and through next generation sequencing to identify the characteristic gene expression profile The GH responsive genes identified with this study can be used for correlation studies on the response to rhGH treatment
Growth hormone deficiency GHD is characterized by a delay in the statural growth in children and is correlated with a worsening of body composition cognitive functions lipid metabolism bone mineralization cardiac performance and exercise in adults Recombinant GH rhGH replacement therapy can correct these alterations and therefore improve the quality of life in treated patients and accelerate growth in children
The optimal dosage of rhGH varies for each patient as the response to treatment suffers from considerable inter-individual variability To date IGF1 is the only available biomarker whose plasma levels correlate with replacement therapy
It is important to underline how somatomedin C does not provide information about the optimal posology of rhGH for each patient in order therefore to predict its adverse events and efficacy
In addition it has been shown that the effects mediated by the somatotropic hormone on some tissues are direct therefore independent of the action of IGF1 whose plasma levels are not in this case predictive of therapeutic response
For this reason it is therefore necessary to identify a more specific biomarker capable of monitoring the efficacy individual responsiveness and any adverse events in patients receiving somatotropic hormone
The GH receptor GHR is expressed in several cells including monocytes It is therefore possible that the response of monocytes to the somatotropic hormone partially mirrors that of the chondrocyte and other cell types Given the difficulty of obtaining osteomuscular biopsies or specific body areas in which GH mediates its biological action the published works have identified the specific cell line in which to study the molecular effects of the hormone in monocytes thanks to their easy accessibility and high number of GHR
In consideration of this the investigators propose to stimulate monocytes of healthy and GHD children in vitro with rhGH and through next generation sequencing to identify the characteristic gene expression profile The GH responsive genes identified with this study can be used for correlation studies on the response to rhGH treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None