Growth Hormone DeficiencyETABIOGHDNCT06294860
Biological Age in Children With GH Deficiency Undergoing Hormone Replacement Therapy
An observational study of Growth Hormone Deficiency and Short Stature, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The primary objective of the study is to evaluate the epigenetic age in children with GH deficiency, before and after 6 months of treatment with growth hormone replacement therapy. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Growth Hormone Deficiency, Short Stature
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jun 2023to 30 Mar 2025
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with isolated growth hormone deficiency
Who may be able to join
- children of both sexes
- age 5-15 years affected by isolated GH deficiency according to the criteria provided by note 39 AIFA for this pathology (short stature: ≤ -3 DS or ≤ -2 DS; growth rate/year ≤ -1.0 DS per age and sex evaluated at a distance of at least six months; GH peak at two different pharmacological stimulation tests < 8 ng/ml).
Who cannot join
- presence of organic hypothalamic-pituitary pathologies (diagnosed through encephalic NMR).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Biological Age in Children With GH Deficiency Undergoing Hormone
The primary objective of the study is to evaluate the epigenetic age in children with GH deficiency, before and after 6 months of treatment with growth hormone replacement therapy. The secondary objective is to correlate the epigenetic age with the auxometric and biochemical parameters used in the clinical-endocrinological practice. The results of the study will be useful to set up the clinical and biochemical follow-up of the hormone replacement therapy with rhGH and to understand the biomolecular mechanisms at the base of the debated "anti" or "pro" aging action of GH, the most important anabolic hormone of the human organism.
Read the detailed description
12 children of both sexes affected by an isolated GH deficiency (defined according to the criteria provided by the note 39 AIFA for this pathology: short stature: ≤ -3 DS or ≤ -2 DS; growth rate/year ≤ -1.0 DS per age and sex evaluated at a distance of at least six months; GH peak at two different pharmacological stimulation tests < 8 ng/ml), recruited at the Regional Reference Centre for Growth Disorders, Istituto Auxologico Italiano, IRCCS, Milano. The exclusion criteria for the study (and from the rhGH treatment) are the presence of organic hypothalamic-pituitary pathologies (diagnosed through encephalic RMN).
In basal conditions (pre-treatment), the clinical and anthropometric/auxometric data (height, weight, BMI) are collected, including the evaluation of the body composition with bioelectrical impedance analysis. The same evaluations is repeated after 6 months of treatment with recombinant growth hormone (see below).
Each subject is treated with replacement therapy with rhGH at a dose of 0.025-0.035 mg/kg body weight per day (or 0.7-1.0 mg/ m2 body surface area per day).
Blood samples for the determination of: glycemia, insulin, HbA1C, triglycerides, total cholesterol, LDL, HDL, hsPCR, IGF-1, osteocalcin, ICTP, and PIIINP are collected at T0 (before the start of the hormone replacement therapy with rhGH) and at T6 (after 6 months of rhGH, approximately 10-12 from the last dosing).
From the leucocytes isolated from the samples taken at T0 and T6, the DNA is extracted. The DNA methylation is performed with sodium bisulfite and PCR- Pyrosequencing.
The biological age (epigenetic) is measured with two algorithms of Zbiec-Piekarska and of Daunay, based on DNA methylation level in specific loci. To have an estimate of the epigenetic age (biological) that is independent of the chronological age, a defined measure defined as age acceleration will be used, for which calculation a linear regression model will be applied with the chronological age as independent variable and the epigenetic age as dependent variable; the difference between the observed value and the predicted value from the model represents the age acceleration due to a properly epigenetic effect. In case the epigenetic age is higher than the chronological age, the age acceleration has a positive value expressed in years, otherwise negative.
- Conditions
- Growth Hormone Deficiency, Short Stature
- Keywords
- Growth hormone deficiency, Replacement therapy, Recombinant growth hormone, Short stature, Biological age, Epigenetic
- Medical subject headings
- Dwarfism, Pituitary, Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hormone replacement therapy with rhGH | Each subject will be treated with hormone replacement therapy with rhGH with a dose of 0.025-0.035 mg/kg body weight per day (or 0.7-1.0 mg/ m2 body surface area per day) for a period of 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of biological (epigenetic) age
The biological age (epigenetic) is measured in basal condition (T0) and after 6 months of treatment with recombinant growth hormone with two algorithms (Zbiec-Piekarska and Daunay), based on DNA methylation level in specific loci. To have an estimate of the epigenetic age (biological) that is independent of the chronological age, we use age acceleration, for whose calculation we apply a linear regression model with the chronological age as independent variable and the epigenetic age as dependent variable; the difference between the observed value and the predicted value from the model is the age acceleration due to a properly epigenetic effect. In case the epigenetic age is higher than the chronological age, the age acceleration has a positive value expressed in years, otherwise negative.
Measured: Baseline and after 6 months of substitutive treatment with recombinant growth hormone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start19 Jun 2023
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
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.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Sartorio, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294860
- Sponsor's protocol ID
- 01C317
- Acronym
- ETABIOGHD
- Status last verified
- Sep 2025
- First submitted
- 28 Feb 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biological Age in Children With GH Deficiency Undergoing Hormone
- ClinicalTrials.gov ID
- NCT06294860
- Acronym / sponsor ID
- ETABIOGHD / 01C317
- Conditions
- Growth Hormone Deficiency, Short Stature
- Keywords
- Growth hormone deficiency, Replacement therapy, Recombinant growth hormone, Short stature, Biological age, Epigenetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 6 Mar 2024 (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 primary objective of the study is to evaluate the epigenetic age in children with GH deficiency, before and after 6 months of treatment with growth hormone replacement therapy. The secondary objective is to correlate the epigenetic age with the auxometric and biochemical parameters used in the clinical-endocrinological practice. The results of the study will be useful to set up the clinical and biochemical follow-up of the hormone replacement therapy with rhGH and to understand the biomolecular mechanisms at the base of the debated "anti" or "pro" aging action of GH, the most important anabolic hormone of the human organism.
Detailed description
12 children of both sexes affected by an isolated GH deficiency (defined according to the criteria provided by the note 39 AIFA for this pathology: short stature: ≤ -3 DS or ≤ -2 DS; growth rate/year ≤ -1.0 DS per age and sex evaluated at a distance of at least six months; GH peak at two different pharmacological stimulation tests < 8 ng/ml), recruited at the Regional Reference Centre for Growth Disorders, Istituto Auxologico Italiano, IRCCS, Milano. The exclusion criteria for the study (and from the rhGH treatment) are the presence of organic hypothalamic-pituitary pathologies (diagnosed through encephalic RMN).
In basal conditions (pre-treatment), the clinical and anthropometric/auxometric data (height, weight, BMI) are collected, including the evaluation of the body composition with bioelectrical impedance analysis. The same evaluations is repeated after 6 months of treatment with recombinant growth hormone (see below).
Each subject is treated with replacement therapy with rhGH at a dose of 0.025-0.035 mg/kg body weight per day (or 0.7-1.0 mg/ m2 body surface area per day).
Blood samples for the determination of: glycemia, insulin, HbA1C, triglycerides, total cholesterol, LDL, HDL, hsPCR, IGF-1, osteocalcin, ICTP, and PIIINP are collected at T0 (before the start of the hormone replacement therapy with rhGH) and at T6 (after 6 months of rhGH, approximately 10-12 from the last dosing).
From the leucocytes isolated from the samples taken at T0 and T6, the DNA is extracted. The DNA methylation is performed with sodium bisulfite and PCR- Pyrosequencing.
The biological age (epigenetic) is measured with two algorithms of Zbiec-Piekarska and of Daunay, based on DNA methylation level in specific loci. To have an estimate of the epigenetic age (biological) that is independent of the chronological age, a defined measure defined as age acceleration will be used, for which calculation a linear regression model will be applied with the chronological age as independent variable and the epigenetic age as dependent variable; the difference between the observed value and the predicted value from the model represents the age acceleration due to a properly epigenetic effect. In case the epigenetic age is higher than the chronological age, the age acceleration has a positive value expressed in years, otherwise negative.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hormone replacement therapy with rhGH | – | –Each subject will be treated with hormone replacement therapy with rhGH with a dose of 0.025-0.035 mg/kg body weight per day (or 0.7-1.0 mg/ m2 body surface area per day) for a period of 6 months. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with isolated growth hormone deficiency
Key inclusion criteria (2 listed)
- children of both sexes
- age 5-15 years affected by isolated GH deficiency according to the criteria provided by note 39 AIFA for this pathology (short stature: ≤ -3 DS or ≤ -2 DS; growth rate/year ≤ -1.0 DS per age and sex evaluated at a distance of at least six months; GH peak at two different pharmacological stimulation tests < 8 ng/ml).
Key exclusion criteria (1 listed)
- presence of organic hypothalamic-pituitary pathologies (diagnosed through encephalic NMR).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of biological (epigenetic) age
Time frame: Baseline and after 6 months of substitutive treatment with recombinant growth hormone
The biological age (epigenetic) is measured in basal condition (T0) and after 6 months of treatment with recombinant growth hormone with two algorithms (Zbiec-Piekarska and Daunay), based on DNA methylation level in specific loci. To have an estimate of the epigenetic age (biological) that is independent of the chronological age, we use age acceleration, for whose calculation we apply a linear regression model with the chronological age as independent variable and the epigenetic age as dependent variable; the difference between the observed value and the predicted value from the model is the age acceleration due to a properly epigenetic effect. In case the epigenetic age is higher than the chronological age, the age acceleration has a positive value expressed in years, otherwise negative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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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.
Alessandro Sartorio, MD principal investigator
Istituto Auxologico Italiano
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 and Short Stature, run by Istituto Auxologico Italiano 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 3 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of biological (epigenetic) age (time frame: Baseline and after 6 months of substitutive treatment with recombinant growth hormone). 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 3 Sep 2025.