BELux Children OutcoME During A(@)Dulthood With GHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > or = 18 years
Diagnosed with child-hood onset growth hormone deficiency (CO-GHD) (no
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Biological Sample
Other interventionClinical examination and blood test. The clinical examination and blood test are considered standard-of-care as they could be performed annually or bi-annually as part of an adult GHD follow-up. Subsequently, the data will be collected directly from the patient's chosen physician.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Patients with regular follow-up for their GHD (treated with rhGH or not)No intervention 0 interventions
Group B: Patients who are lost to follow-up or not regularly followed for their GHDActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Determine the proportion of adult CO-GHD patients who continue to receive regular. medical follow-up
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.
Time frame
BaselineSecondary outcomes
1
Assessment of the regularity of follow-up and compliance with a questionnaire.
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.
Time frame
Baseline2
Assessment of the possible comorbidities and health issues with a questionnaire.
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.
Time frame
Baseline3
Assessment of the metabolic profile in adulthood.
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.
Time frame
1 year per patient4
Describe those data according to treatment adherence.
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov