Not Yet Recruiting
NA
INTERVENTIONAL
NCT07173036
Evaluation of (Cardio)Metabolic and Auxological Outcomes of GHD Patients Under rhGH or LAGH With Stratification According to IGF-1 Levels
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Interventions
Name:
metabolic and auxological outcomes
Type:
OTHER
Description:
Evaluation over a three-year period following the initiation of treatment with daily recombinant human growth hormone (rhGH)
Name:
metabolic and auxological outcomes
Type:
OTHER
Description:
Evaluation over a three-year period following the initiation of treatment with weekly long-acting growth hormone (LAGH).
Primary Outcomes
Measure:
Auxological evaluation_1
TimeFrame:
3 years
Description:
Primary outcome measures included change in stature (in cm and SDS) over the course of the study.
Measure:
Auxological evaluation_2
TimeFrame:
3 years
Description:
Primary outcome measures included change in weight (in kgs and SDS) over the course of the study.
Measure:
Auxological evaluation_3
TimeFrame:
3 years
Description:
Primary outcome measures included change in BMI (in kg/m2) over the course of the study.
Measure:
Evaluation of the blood pressure
TimeFrame:
3 years
Description:
Measure of the systolic and diastolic blood pressure (in mmHg) with a sphygmomanometer
Measure:
Evaluation of waist circumference
TimeFrame:
3 years
Description:
Measure of waist circumference (in cm) with a meter
Measure:
Evaluation of clinical signs of puberty (Tanner stage) and androgenism
TimeFrame:
3 years
Description:
Evaluation of clinical signs of puberty (Tanner stage) and androgenism.
Measure:
Metabolic evaluation_1
TimeFrame:
3 years
Description:
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting glycemia (mg/dl).
Measure:
Metabolic evaluation_2
TimeFrame:
3 years
Description:
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting insulin (pmol/L).
Measure:
Metabolic evaluation_3
TimeFrame:
3 years
Description:
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of hemoglobin A1c in diabetic patients (%).
Measure:
Metabolic evaluation_4
TimeFrame:
3 years
Description:
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of transaminases (UI/L).
Measure:
Metabolic evaluation_5
TimeFrame:
3 years
Description:
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of lipid profile (mg/dL).
Measure:
Metabolic evaluation_6
TimeFrame:
3 years
Description:
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of creatinine (mg/dL).
Measure:
Metabolic evaluation_7
TimeFrame:
3 years
Description:
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of alkaline phosphatase (UI/L).
Measure:
Metabolic evaluation_8
TimeFrame:
3 years
Description:
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of calcium (mmol/L).
Measure:
Metabolic evaluation_9
TimeFrame:
3 years
Description:
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of phosphorus (mmol/L).
Measure:
Metabolic evaluation_10
TimeFrame:
3 years
Description:
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).
Measure:
Bone markers_1
TimeFrame:
3 years
Description:
Measurements in blood samples of bone markers such as procollagen type 1 N-terminal propeptide (µg/L).
Measure:
Bone markers_2
TimeFrame:
3 years
Description:
Measurements in blood samples of bone markers such as insulin-like growth factor (ng/mL).
Measure:
Bone markers_3
TimeFrame:
3 years
Description:
Measurements in blood samples of bone markers such as insulin-like growth factor binding protein (µL/mL).
Measure:
Endothelial stress and inflammatory markers_1
TimeFrame:
3 years
Description:
Measurements in blood samples of endothelial stress and inflammatory markers such as asymmetric dimethylarginine (µmol/L).
Measure:
Endothelial stress and inflammatory markers_2
TimeFrame:
3 years
Description:
Measurements in blood samples of endothelial stress and inflammatory markers such as TNF-a (pg/mL).
Measure:
Endothelial stress and inflammatory markers_3
TimeFrame:
3 years
Description:
Measurements in blood samples of endothelial stress and inflammatory markers such as VEGF (pg/mL).
Measure:
Endothelial stress and inflammatory markers_4
TimeFrame:
3 years
Description:
Measurements in blood samples of endothelial stress and inflammatory markers such as IL-6 (pg/mL).
Measure:
Radiological evaluation of cIMT
TimeFrame:
3 years
Description:
Measurements of cIMT (mm) using Doppler ultrasound.
Measure:
Radiological evaluation of body fat distribution
TimeFrame:
3 years
Description:
Measurements of body fat distribution (g/cm2) using DEXA-Scan.
Trial Information
NCT ID
NCT07173036
Status
Not Yet Recruiting
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Last Updated
December 15, 2025