BELux Children OutcoME During A(@)Dulthood With GHD (BELCOME@GHD)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Not yet enrolling

Conditions: Adult Growth Hormone Deficiency; Growth Hormone Deficiency

Treatments: Other: Biological Sample

Study type: Interventional

Funder types: Other

Identifiers

NCT06694506

CUSL

Details and patient eligibility

About

Our objective is to evaluate the outcome in adulthood of Belgian and Luxembourgish patients treated with rhGH during childhood for CO-GHD. The primary goal is to determine the proportion of adult CO-GHD patients who continue to receive regular medical follow-up and those still undergoing rhGH therapy using a questionnaire. Secondary objectives include assessing the regularity of follow-up and compliance with treatment in adulthood, evaluating possible comorbidities, health issues, lifestyle, living environment, and quality of life. Additionally, we aim to assess the metabolic profile in adulthood, particularly focusing on BMI, glycemic, and lipid data, for patients who consent to share their current clinical and biological data. Data will be described according to treatment adherence and CO-GHD etiology/phenotypes (e.g., idiopathic vs. organic GHD, isolated vs. combined GHD, partial vs. severe GHD).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > or = 18 years
• Diagnosed with child-hood onset growth hormone deficiency (CO-GHD) (no exclusion criteria: isolated or multiple GHD, idiopathic or organic, severe or partial)
• Registered in the BELGROW registry (informed consent at the time of inclusion in registry)
• Stopped treatment with rhGH for growth after 2011
• Persistent GHD at the end of growth

Exclusion criteria

• No exclusion criteria

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Patients with regular follow-up for their GHD (treated with rhGH or not)

No Intervention group

Description:

Patients with regular follow-up for their GHD (treated with rhGH or not) in a adult endocrinology department including a clinical examination and endocrine blood work-up at least once a year

Patients who are lost to follow-up or not regularly followed for their GHD

Active Comparator group

Description:

Patients who are lost to follow-up or not regularly followed for their GHD (or only followed by their GP with no endocrine assessment)

Treatment:

Other: Biological Sample