NCT07173036

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-03-01
• Completion: 2031-09-01
• First posted: 2025-09-15
• Last updated: 2026-02-12