Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07173036

Evaluation of (Cardio)Metabolic and Auxological Outcomes of GHD Patients Under rhGH or LAGH With Stratification According to IGF-1 Levels

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with growth hormone deficiency (GHD)
  • Treated with growth hormone (rhGH or LAGH)

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

metabolic and auxological outcomes

Other

Evaluation over a three-year period following the initiation of treatment with daily recombinant human growth hormone (rhGH)

Primary outcomes

  1. Auxological evaluation_1

    Time frame: 3 years

    Primary outcome measures included change in stature (in cm and SDS) over the course of the study.

  2. Auxological evaluation_2

    Time frame: 3 years

    Primary outcome measures included change in weight (in kgs and SDS) over the course of the study.

  3. Auxological evaluation_3

    Time frame: 3 years

    Primary outcome measures included change in BMI (in kg/m2) over the course of the study.

  4. Evaluation of the blood pressure

    Time frame: 3 years

    Measure of the systolic and diastolic blood pressure (in mmHg) with a sphygmomanometer

  5. Evaluation of waist circumference

    Time frame: 3 years

    Measure of waist circumference (in cm) with a meter

  6. Evaluation of clinical signs of puberty (Tanner stage) and androgenism

    Time frame: 3 years

    Evaluation of clinical signs of puberty (Tanner stage) and androgenism.

  7. Metabolic evaluation_1

    Time frame: 3 years

    Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting glycemia (mg/dl).

  8. Metabolic evaluation_2

    Time frame: 3 years

    Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting insulin (pmol/L).

  9. Metabolic evaluation_3

    Time frame: 3 years

    Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of hemoglobin A1c in diabetic patients (%).

  10. Metabolic evaluation_4

    Time frame: 3 years

    Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of transaminases (UI/L).

  11. Metabolic evaluation_5

    Time frame: 3 years

    Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of lipid profile (mg/dL).

  12. Metabolic evaluation_6

    Time frame: 3 years

    Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of creatinine (mg/dL).

  13. Metabolic evaluation_7

    Time frame: 3 years

    Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of alkaline phosphatase (UI/L).

  14. Metabolic evaluation_8

    Time frame: 3 years

    Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of calcium (mmol/L).

  15. Metabolic evaluation_9

    Time frame: 3 years

    Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of phosphorus (mmol/L).

  16. Metabolic evaluation_10

    Time frame: 3 years

    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).

  17. Bone markers_1

    Time frame: 3 years

    Measurements in blood samples of bone markers such as procollagen type 1 N-terminal propeptide (µg/L).

  18. Bone markers_2

    Time frame: 3 years

    Measurements in blood samples of bone markers such as insulin-like growth factor (ng/mL).

  19. Bone markers_3

    Time frame: 3 years

    Measurements in blood samples of bone markers such as insulin-like growth factor binding protein (µL/mL).

  20. Endothelial stress and inflammatory markers_1

    Time frame: 3 years

    Measurements in blood samples of endothelial stress and inflammatory markers such as asymmetric dimethylarginine (µmol/L).

  21. Endothelial stress and inflammatory markers_2

    Time frame: 3 years

    Measurements in blood samples of endothelial stress and inflammatory markers such as TNF-a (pg/mL).

  22. Endothelial stress and inflammatory markers_3

    Time frame: 3 years

    Measurements in blood samples of endothelial stress and inflammatory markers such as VEGF (pg/mL).

  23. Endothelial stress and inflammatory markers_4

    Time frame: 3 years

    Measurements in blood samples of endothelial stress and inflammatory markers such as IL-6 (pg/mL).

  24. Radiological evaluation of cIMT

    Time frame: 3 years

    Measurements of cIMT (mm) using Doppler ultrasound.

  25. Radiological evaluation of body fat distribution

    Time frame: 3 years

    Measurements of body fat distribution (g/cm2) using DEXA-Scan.

Secondary outcomes

  1. comparison with patients under weekly LAGH

    Time frame: 3 years

    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.

  2. Stratification of the metabolic profile of the patients according to IGF-1 levels

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Laure Boutsen, MD

CONTACT

[email protected]

+32276441370

Micheline Grillet, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Evaluation of (Cardio)Metabolic and Auxological Outcomes of GHD Patients Under Recombinant Human or Long-acting Growth Hormone With Stratification According to IGF-1 Levels

Acronym: METAB-BELGROW

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Sep 15, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.