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

NCT ID: NCT07173036

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2031-09-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

rhGH cohort

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

Group Type: OTHER

metabolic and auxological outcomes

Intervention Type: OTHER

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

LAGH cohort

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

Group Type: OTHER

metabolic and auxological outcomes

Intervention Type: OTHER

Evaluation over a three-year period following the initiation of treatment with weekly long-acting growth hormone (LAGH).

Interventions

metabolic and auxological outcomes

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

Intervention Type: OTHER

metabolic and auxological outcomes

Evaluation over a three-year period following the initiation of treatment with weekly long-acting growth hormone (LAGH).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Lysy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Central Contacts

Laure Boutsen, MD

Role: CONTACT

laure.boutsen@saintluc.uclouvain.be

+32276441370

Micheline Grillet, PhD

Role: CONTACT

micheline.grillet@saintluc.uclouvain.be

Other Identifiers

2025/02JUI/216

Identifier Type: -

Identifier Source: org_study_id