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Search / Trial NCT06294860

Biological Age in Children With GH Deficiency Undergoing Hormone Replacement Therapy

Launched by ISTITUTO AUXOLOGICO ITALIANO · Feb 28, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Growth Hormone Deficiency Replacement Therapy Recombinant Growth Hormone Short Stature Biological Age Epigenetic

ClinConnect Summary

This clinical trial is studying how growth hormone (GH) therapy affects the biological age of children who have a condition called growth hormone deficiency, which means they may be shorter than their peers. The researchers want to see how the treatment changes the children’s epigenetic age—a measure of biological aging—after six months of using growth hormone replacement therapy. They will also look at how this biological age relates to other growth measurements and blood tests that doctors typically use.

To participate in this study, children aged 5 to 15 who are diagnosed with isolated growth hormone deficiency may be eligible. This means they must have specific growth patterns that show they are shorter than expected for their age and sex, along with certain test results indicating low levels of growth hormone. Participants will undergo assessments at the start and after six months of treatment, helping doctors better understand how growth hormone affects growth and aging in children. It’s important to note that children with specific brain-related issues will not be included in this study.

Gender

ALL

Eligibility 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).

About Istituto Auxologico Italiano

Istituto Auxologico Italiano is a prominent Italian research institute dedicated to advancing medical science and improving patient care through innovative clinical research. With a strong focus on metabolic diseases, cardiovascular health, and neuropsychological disorders, the institute integrates clinical practice with cutting-edge research to foster the development of new therapeutic strategies. Committed to ethical standards and patient safety, Istituto Auxologico Italiano collaborates with various national and international partners, contributing significantly to the global medical community while ensuring high-quality care and support for its patients.

Locations

Milano, , Italy

Patients applied

0 patients applied

Trial Officials

Alessandro Sartorio, MD

Principal Investigator

Istituto Auxologico Italiano

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported