Growth Hormone DeficiencyGEMGHNCT04352712
Gene Expression in Monocytes of Growth Hormone Deficient Children
An observational study of Growth Hormone Deficiency, run by University of Salerno at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 10 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- blood sampling
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2019to 15 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- Men only
- Healthy volunteers accepted
- Child
Study population: primary care clinic
Who may be able to join
- Height lower the 3th percentile
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Medicine and Surgery, Univeristy of Salerno
Baronissi, Salerno, 84081
Mario Vitale, MD, +39 089672539, mavitale@unisa.it
Mario Vitale, MD
About this study
Official title: Growth Hormone Modulated Gene Expression in Monocytes of Healthy and Growth Hormone Deficient Children
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.
Read more
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.
- Conditions
- Growth Hormone Deficiency
- Being tested
- blood sampling
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Healthy Children | healthy children, untreated, donors of monocytes Receives: Other: blood sampling | |
| GHD children | GHD children, untreated, donors of monocytes Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression in monocytes of GHD children
analysis of RNA-seq of monocytes of healthy and GHD children
Measured: one year
Secondary outcomes (1)
gene expression in monocytes modulated by GH
analysis of RNA-seq of monocytes of healthy and GHD children, stimulated with GH in culture
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start15 Apr 2019
- Primary completion15 Apr 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Vitale, University of Salerno
- Investigators
- Mario Vitale, MD, Study director, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352712
- Sponsor's protocol ID
- GHUSalerno
- Acronym
- GEMGH
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Modulated Gene Expression in Monocytes of Healthy and Growth Hormone Deficient Children
- ClinicalTrials.gov ID
- NCT04352712
- Acronym / sponsor ID
- GEMGH / GHUSalerno
- Conditions
- Growth Hormone Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Children | – | Other: blood samplinghealthy children, untreated, donors of monocytes |
| GHD children | – | Other: blood samplingGHD children, untreated, donors of monocytes |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Height lower the 3th percentile
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingblood sampling | Other | GHD children, Healthy Children |
Primary outcome
gene expression in monocytes of GHD children
Time frame: one year
analysis of RNA-seq of monocytes of healthy and GHD children
1 secondary outcome
gene expression in monocytes modulated by GH
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Vitale, MD study director
University of Salerno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by University of Salerno at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Vitale, MD (393482652847, mavitale@unisa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene expression in monocytes of GHD children (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020.