Growth Hormone DeficiencyMETAB-BELGROWNCT07173036

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

A study testing metabolic and auxological outcomes in people with Growth Hormone Deficiency, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 5 to 18 years
Conditions the study is for: Growth Hormone Deficiency
What is being tested?: metabolic and auxological outcomes
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: No sites listed yet
Study dates: 1 Jul 2026to 1 Sep 2031
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

No exclusion criteria

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Laure Boutsen, MD contact

+32276441370

laure.boutsen@saintluc.uclouvain.be

Micheline Grillet, PhD contact

micheline.grillet@saintluc.uclouvain.be

About this study

Official 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

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
Being tested: metabolic and auxological outcomes
Keywords: metabolic outcomes, auxological outcomes, recombinant human growth hormone, long acting growth hormone
Medical subject headings: Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

metabolic and auxological outcomesOther
Evaluation over a three-year period following the initiation of treatment with daily recombinant human growth hormone (rhGH)
metabolic and auxological outcomesOther
Evaluation over a three-year period following the initiation of treatment with weekly long-acting growth hormone (LAGH).

Study groups in NCT07173036
Study group	Role	What they receive
rhGH cohort	Other	Patients with GHD who receive daily rhGH (dose titration according to guidelines i.e. 25-35 micrograms/kg body weight/day) Receives: 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) Receives: Other: metabolic and auxological outcomes

What is being measured

The primary outcome is the main question the study is designed to answer.

Auxological evaluation_1
Primary outcome measures included change in stature (in cm and SDS) over the course of the study.
Measured: 3 years
Auxological evaluation_2
Primary outcome measures included change in weight (in kgs and SDS) over the course of the study.
Measured: 3 years
Auxological evaluation_3
Primary outcome measures included change in BMI (in kg/m2) over the course of the study.
Measured: 3 years
Evaluation of the blood pressure
Measure of the systolic and diastolic blood pressure (in mmHg) with a sphygmomanometer
Measured: 3 years
Evaluation of waist circumference
Measure of waist circumference (in cm) with a meter
Measured: 3 years
Evaluation of clinical signs of puberty (Tanner stage) and androgenism
Evaluation of clinical signs of puberty (Tanner stage) and androgenism.
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 3 years
Bone markers_1
Measurements in blood samples of bone markers such as procollagen type 1 N-terminal propeptide (µg/L).
Measured: 3 years
Bone markers_2
Measurements in blood samples of bone markers such as insulin-like growth factor (ng/mL).
Measured: 3 years
Bone markers_3
Measurements in blood samples of bone markers such as insulin-like growth factor binding protein (µL/mL).
Measured: 3 years
Endothelial stress and inflammatory markers_1
Measurements in blood samples of endothelial stress and inflammatory markers such as asymmetric dimethylarginine (µmol/L).
Measured: 3 years
Endothelial stress and inflammatory markers_2
Measurements in blood samples of endothelial stress and inflammatory markers such as TNF-a (pg/mL).
Measured: 3 years
Endothelial stress and inflammatory markers_3
Measurements in blood samples of endothelial stress and inflammatory markers such as VEGF (pg/mL).
Measured: 3 years
Endothelial stress and inflammatory markers_4
Measurements in blood samples of endothelial stress and inflammatory markers such as IL-6 (pg/mL).
Measured: 3 years
Radiological evaluation of cIMT
Measurements of cIMT (mm) using Doppler ultrasound.
Measured: 3 years
Radiological evaluation of body fat distribution
Measurements of body fat distribution (g/cm2) using DEXA-Scan.
Measured: 3 years

Secondary outcomes (2)

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.
Measured: 3 years
Stratification of the metabolic profile of the patients according to IGF-1 levels
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20261 Sep 2031

First posted15 Sep 2025
Study start1 Jul 2026 (estimated)
Primary completion1 Sep 2031 (estimated)
Study completion1 Sep 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07173036
Sponsor's protocol ID: 2025/02JUI/216
Acronym: METAB-BELGROW
Status last verified: May 2026
First submitted: 13 Jun 2025
Last updated: 11 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Laure Boutsen, MD

+32276441370

laure.boutsen@saintluc.uclouvain.be

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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