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

NCT07173036 | Not Yet Recruiting

• 1 other identifier: 2025/02JUI/216
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Growth Hormone Deficiency

Keywords

metabolic outcomes; auxological outcomes; recombinant human growth hormone; long acting growth hormone

Outcome Measures

Primary Outcomes (25)

• Auxological evaluation_1

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

  3 years

• Auxological evaluation_2

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

  3 years

• Auxological evaluation_3

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

  3 years

• Evaluation of the blood pressure

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

  3 years

• Evaluation of waist circumference

  Measure of waist circumference (in cm) with a meter

  3 years

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

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

  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).

  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).

  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 (%).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  3 years

• Bone markers_1

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

  3 years

• Bone markers_2

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

  3 years

• Bone markers_3

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

  3 years

• Endothelial stress and inflammatory markers_1

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

  3 years

• Endothelial stress and inflammatory markers_2

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

  3 years

• Endothelial stress and inflammatory markers_3

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

  3 years

• Endothelial stress and inflammatory markers_4

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

  3 years

• Radiological evaluation of cIMT

  Measurements of cIMT (mm) using Doppler ultrasound.

  3 years

• Radiological evaluation of body fat distribution

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

  3 years

Secondary Outcomes (2)

• comparison with patients under weekly LAGH

  3 years

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

  3 years

Study Arms (2)

rhGH cohort

OTHER

Patients with GHD who receive daily rhGH (dose titration according to guidelines i.e. 25-35 micrograms/kg body weight/day)

Other: metabolic and auxological outcomes

LAGH cohort

OTHER

Patients with GHD who receive weekly LAGH (dose titration according to guidelines i.e. for somatrogon 0.66 milligrams/kg body weight/week)

Other: metabolic and auxological outcomes

Interventions

metabolic and auxological outcomes OTHER

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

rhGH cohort

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Metabolic Networks and Pathways

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

• Philippe Lysy, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laure Boutsen, MD

CONTACT

+32276441370; laure.boutsen@saintluc.uclouvain.be

Micheline Grillet, PhD

CONTACT

micheline.grillet@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be classified into two groups (depending on their treatment as decided by their pediatric endocrinologist): * patients with GHD who receive daily rhGH= rhGH cohort * patients with GHD who receive weekly LAGH= LAGH cohort

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: September 15, 2025
• Study Start: March 1, 2026
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2031
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share