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METAB-BELGROWMetabolic Outcomes in Belgian Children with Growth Hormone Deficiency

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What is being tested

metabolic and auxological outcomes

Other
Who is being recruted

Bone Diseases+10

+ Bone Diseases, Developmental

+ Bone Diseases, Endocrine

From 5 to 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain
Study ContactLaure Boutsen, MDMore contacts
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

The study focuses on Belgian children who have a condition called growth hormone deficiency (GHD), which affects their growth and development. The goal is to understand how different types of growth hormone treatments impact the children's metabolism over three years. Some children will receive daily doses of recombinant human growth hormone (rhGH), while others will be treated with a long-acting form given weekly. The research aims to compare these two treatment methods to see which one might offer better outcomes in terms of metabolic health. This study is important as it could help determine the most effective treatment approach for children with GHD, potentially leading to better growth and health. Participants in the study will attend regular follow-up visits every 6 to 12 months, where various health parameters will be recorded. These include clinical assessments, measurements of growth, and biological tests. Additional tests will check for metabolic markers and other health indicators. In some cases, more detailed examinations like DEXA scans to look at body fat and tests to measure the thickness of artery walls will be conducted. These assessments will help researchers understand the effects of the treatments on the children's overall health and growth. The study will also monitor any potential risks or side effects of the treatments.

Official TitleEvaluation of (Cardio)Metabolic and Auxological Outcomes of GHD Patients Under Recombinant Human or Long-acting Growth Hormone With Stratification According to IGF-1 Levels
NCT07173036
Principal SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain
Study ContactLaure Boutsen, MDMore contacts
Last updated: February 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 5 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, DevelopmentalBone Diseases, EndocrineBrain DiseasesCentral Nervous System DiseasesDwarfismDwarfism, PituitaryEndocrine System DiseasesHypopituitarismHypothalamic DiseasesMusculoskeletal DiseasesNervous System DiseasesPituitary Diseases

Criteria

2 inclusion criteria required to participate
Treated with growth hormone (rhGH or LAGH)

Diagnosed with growth hormone deficiency (GHD)

1 exclusion criteria prevent from participating
No exclusion criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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