Evaluating biological age in children with growth hormone deficiency undergoing treatment
Evaluation of Biological Age in Children With GH Deficiency Undergoing Hormone
This study is testing how growth hormone treatment affects the biological age of children with growth hormone deficiency by looking at their health and growth before and after six months of therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 5 Years to 15 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT06294860 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the epigenetic age of children diagnosed with growth hormone deficiency before and after six months of growth hormone replacement therapy. It involves collecting clinical and anthropometric data, including height, weight, and body composition, as well as blood samples to analyze various biochemical parameters. The study will help understand the effects of growth hormone therapy on biological aging and its implications for clinical practice in managing growth disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5-15 years with isolated growth hormone deficiency as defined by specific clinical criteria.
Not a fit: Patients with organic hypothalamic-pituitary pathologies will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of growth hormone therapy in improving growth outcomes and biological age in affected children.
How similar studies have performed: While the specific approach of evaluating epigenetic age in this context may be novel, similar studies have shown promising results in understanding the effects of growth hormone therapy on growth and metabolic parameters.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Milano
- Istituto Auxologico Italiano — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Alessandro Sartorio, MD — Istituto Auxologico Italiano
- Study coordinator: Alessandro Sartorio, MD
- Email: sartorio@auxologico.it
- Phone: +390261911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.