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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
300
Evaluation over a three-year period following the initiation of treatment with daily recombinant human growth hormone (rhGH)
Evaluation 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.
Time frame: 3 years
Auxological evaluation_2
Primary outcome measures included change in weight (in kgs and SDS) over the course of the study.
Time frame: 3 years
Auxological evaluation_3
Primary outcome measures included change in BMI (in kg/m2) over the course of the study.
Time frame: 3 years
Evaluation of the blood pressure
Measure of the systolic and diastolic blood pressure (in mmHg) with a sphygmomanometer
Time frame: 3 years
Evaluation of waist circumference
Measure of waist circumference (in cm) with a meter
Time frame: 3 years
Evaluation of clinical signs of puberty (Tanner stage) and androgenism
Evaluation of clinical signs of puberty (Tanner stage) and androgenism.
Time frame: 3 years
Metabolic evaluation_1
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting glycemia (mg/dl).
Time frame: 3 years
Metabolic evaluation_2
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting insulin (pmol/L).
Time frame: 3 years
Metabolic evaluation_3
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of hemoglobin A1c in diabetic patients (%).
Time frame: 3 years
Metabolic evaluation_4
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of transaminases (UI/L).
Time frame: 3 years
Metabolic evaluation_5
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of lipid profile (mg/dL).
Time frame: 3 years
Metabolic evaluation_6
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of creatinine (mg/dL).
Time frame: 3 years
Metabolic evaluation_7
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of alkaline phosphatase (UI/L).
Time frame: 3 years
Metabolic evaluation_8
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of calcium (mmol/L).
Time frame: 3 years
Metabolic evaluation_9
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of phosphorus (mmol/L).
Time frame: 3 years
Metabolic evaluation_10
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of insulin-like growth factor 1 levels (ng/mL).
Time frame: 3 years
Bone markers_1
Measurements in blood samples of bone markers such as procollagen type 1 N-terminal propeptide (µg/L).
Time frame: 3 years
Bone markers_2
Measurements in blood samples of bone markers such as insulin-like growth factor (ng/mL).
Time frame: 3 years
Bone markers_3
Measurements in blood samples of bone markers such as insulin-like growth factor binding protein (µL/mL).
Time frame: 3 years
Endothelial stress and inflammatory markers_1
Measurements in blood samples of endothelial stress and inflammatory markers such as asymmetric dimethylarginine (µmol/L).
Time frame: 3 years
Endothelial stress and inflammatory markers_2
Measurements in blood samples of endothelial stress and inflammatory markers such as TNF-a (pg/mL).
Time frame: 3 years
Endothelial stress and inflammatory markers_3
Measurements in blood samples of endothelial stress and inflammatory markers such as VEGF (pg/mL).
Time frame: 3 years
Endothelial stress and inflammatory markers_4
Measurements in blood samples of endothelial stress and inflammatory markers such as IL-6 (pg/mL).
Time frame: 3 years
Radiological evaluation of cIMT
Measurements of cIMT (mm) using Doppler ultrasound.
Time frame: 3 years
Radiological evaluation of body fat distribution
Measurements of body fat distribution (g/cm2) using DEXA-Scan.
Time frame: 3 years
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.
Time frame: 3 years
Stratification of the metabolic profile of the patients according to IGF-1 levels
Time frame: 3 years
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