Body composition after daily versus long-acting growth hormone in children
Assessment of Body Composition in Children Treated With Growth Hormone for the Indication of Isolated Non-acquired Growth Hormone Deficiency.
See if long-acting versus daily growth hormone changes body weight and body composition in children aged 3–17 with isolated growth hormone deficiency.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT07333521 on ClinicalTrials.gov |
What this trial studies
This observational study follows treatment‑naïve children aged 3–17 with isolated non‑acquired growth hormone deficiency who are starting either daily or long‑acting growth hormone. Investigators will collect auxological measurements (height, weight, BMI SDS) and body composition by bioelectrical impedance over time to compare early and longer‑term changes. The protocol focuses on the first year when increases in BMI have been reported with long‑acting formulations and will track whether those changes normalize with prolonged treatment. Data are collected during routine care at Hôpital Necker‑Enfants Malades to provide real‑world evidence that complements controlled trials.
Who should consider this trial
Good fit: Children aged 3–17 with confirmed isolated non‑acquired growth hormone deficiency who are growth hormone treatment‑naïve, have BMI ≤ +3 SD, no multiple pituitary insufficiency, no diabetes or known eating disorders, and whose parents and child consent to participate.
Not a fit: Children with acquired growth hormone deficiency, multiple pituitary hormone deficiencies, pre-existing diabetes, known eating disorders, prior growth hormone treatment, or BMI > +3 SD are excluded and unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the results could help doctors choose and monitor growth hormone formulations to limit unwanted changes in weight and body composition.
How similar studies have performed: Phase III trials have shown long‑acting growth hormone preparations are non‑inferior for growth outcomes but have reported early increases in BMI, and real‑world cohorts suggest those BMI increases may be transient and normalize with longer follow‑up.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 3 to 17 years inclusive. * Confirmed diagnosis of growth hormone deficiency. * Indication for treatment with daily or depot growth hormone. * Growth hormone treatment naïve.- Holders of parental authority and children or adolescents informed and consenting to participate in the study. Exclusion Criteria: * BMI greater than +3 SD. * Multiple pituitary insufficiency. * Acquired growth hormone insufficiency. * Patient with type 1 or type 2 diabetes. * Known eating disorders.
Where this trial is running
Paris
- Hôpital Necker-Enfants Malades — Paris, France (Recruiting)
Study contacts
- Principal investigator: Michel MD, PhD POLAK, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Michel MD, PhD POLAK, MD, PhD
- Email: michel.polak@aphp.fr
- Phone: 01 44 49 48 02
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.