BELux Children OutcoME During A(@)Dulthood With GHD
- Conditions
- Growth Hormone DeficiencyAdult Growth Hormone Deficiency
- Registration Number
- NCT06694506
- Lead Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- No exclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Determine the proportion of adult CO-GHD patients who continue to receive regular. medical follow-up Baseline Using our questionnaire, the primary objective is to determine the proportion of adult CO-GHD patients who continue to receive regular medical follow-up (and where/by who) and the proportion of patients still undergoing rhGH therapy.
- Secondary Outcome Measures
Name Time Method Assessment of the regularity of follow-up and compliance with a questionnaire. Baseline Assessment of the regularity of follow-up and compliance to treatment in adulthood (in patients that are still followed and/or treated with rhGH therapy), with the help of a questionnaire created by the research team.
Assessment of the possible comorbidities and health issues with a questionnaire. Baseline Assessment of the possible comorbidities and health issues, lifestyle, living environment and quality of live (all patients) in adulthood. with the help of a questionnaire created by the research team.
Assessment of the metabolic profile in adulthood. 1 year per patient Assessment of the metabolic profile in adulthood - particularly in relation to BMI, glycemic and lipid data. (fasting glycemia, fasting insulin, hemoglobin A1c, transaminase levels, lipid profile (total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides), insulin-like growth factor 1 (IGF-1) levels, and other hormone levels (thyroid-stimulating hormone (TSH), thyroxine (T4), prolactin (PRL), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol/testosterone, cortisol).). Each of these data will be compared with the clinical data in the same way.
Describe those data according to treatment adherence. Baseline Describe those data according to treatment adherence and CO- GHD etiology/phenotypes (e.g. idiopathic vs organic GHD, isolated vs combined GHD, partial vs severe GHD) The questionnaire will provide us with information on patients' adherence to treatment.
Trial Locations
- Locations (1)
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Woluwe-saint-lambert, Belgium