- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06294860
Biological Age in Children With GH Deficiency Undergoing Hormone Replacement Therapy (ETABIOGHD)
Evaluation of Biological Age in Children With GH Deficiency Undergoing Hormone
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alessandro Sartorio, MD
- Phone Number: 2426 +390261911
- Email: sartorio@auxologico.it
Study Contact Backup
- Name: Luca Grappiolo, Dr.
- Phone Number: 2894 +390261911
Study Locations
-
-
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Milano, Italy, 20145
- Recruiting
- Istituto Auxologico Italiano
-
Contact:
- Alessandro Sartorio
- Phone Number: 2426 +390261911
- Email: sartorio@auxologico.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- presence of organic hypothalamic-pituitary pathologies (diagnosed through encephalic NMR).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and after 6 months of substitutive treatment with recombinant growth hormone
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alessandro Sartorio, MD, Istituto Auxologico Italiano
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01C317
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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