Growth Hormone Deficiency Clinical Trial
— GEMGHOfficial title:
Growth Hormone Modulated Gene Expression in Monocytes of Healthy and Growth Hormone Deficient Children
NCT number | NCT04352712 |
Other study ID # | GHUSalerno |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 15, 2019 |
Est. completion date | April 15, 2021 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | April 15, 2021 |
Est. primary completion date | April 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 6 Years to 10 Years |
Eligibility |
Inclusion Criteria: - Height lower the 3th percentile Exclusion Criteria: - Any endocrinopathy - Liver, kidney or haemolymphopoietic system disorders - Celiac disease or other chronic malabsorption conditions - Genetic syndromes (such as Turner's S., Cystic fibrosis or Down S.) - Drug therapies interfering with growth |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Medicine and Surgery, Univeristy of Salerno | Baronissi | Salerno |
Lead Sponsor | Collaborator |
---|---|
University of Salerno |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | gene expression in monocytes of GHD children | analysis of RNA-seq of monocytes of healthy and GHD children | one year | |
Secondary | gene expression in monocytes modulated by GH | analysis of RNA-seq of monocytes of healthy and GHD children, stimulated with GH in culture | one year |
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