The METAB-BELGROW-LAGH study aims to prospectively evaluate the metabolic outcomes of Belgian children diagnosed with growth hormone deficiency (GHD) over a three-year period following the initiation of treatment with either daily recombinant human growth hormone (rhGH) or weekly long-acting growth hormone (LAGH). Patients will be stratified according to their IGF-1 levels. The primary objective is to assess the metabolic outcomes of children treated with daily rhGH over the first three years. The secondary objectives include comparing the metabolic outcomes between patients treated with daily rhGH and those treated with weekly LAGH, and characterizing metabolic profiles based on IGF-1 levels. To achieve these objectives, both standard-of-care (SOC) and additional data will be collected at scheduled follow-up visits (baseline, 6, 12, 24, and 36 months), including clinical, auxological, and biological parameters. Additional metabolic markers, inflammatory and endothelial biomarkers will be assessed. In a subset of patients, carotid intima-media thickness (cIMT) and body fat distribution (via DEXA-scan) will also be measured.
Diagnosed with growth hormone deficiency (GHD)
Treated with growth hormone (rhGH or LAGH)
No exclusion criteria
Parallel
metabolic and auxological outcomes
Other interventionEvaluation over a three-year period following the initiation of treatment with daily recombinant human growth hormone (rhGH)
metabolic and auxological outcomes
Other interventionEvaluation over a three-year period following the initiation of treatment with weekly long-acting growth hormone (LAGH).
Auxological evaluation_1
Primary outcome measures included change in stature (in cm and SDS) over the course of the study.
Auxological evaluation_2
Primary outcome measures included change in weight (in kgs and SDS) over the course of the study.
Auxological evaluation_3
Primary outcome measures included change in BMI (in kg/m2) over the course of the study.
Evaluation of the blood pressure
Measure of the systolic and diastolic blood pressure (in mmHg) with a sphygmomanometer
comparison with patients under weekly LAGH
Data obtained for patients with daily rhGH will be compared to data obtained for patients with weekly LAGH treatment. Same measurement description as for the primary outcomes.
Stratification of the metabolic profile of the patients according to IGF-1 levels
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
