Evaluation of (Cardio)Metabolic and Auxological Outcomes of GHD Patients Under rhGH or LAGH With Stratification According to IGF-1 Levels
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: metabolic and auxological outcomes, metabolic and auxological outcomes.
- Who it may be relevant to
- Registry conditions: Growth Hormone Deficiency. Basic parameters: 5 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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).
Primary outcome measures
- Auxological evaluation_1 [Time frame: 3 years]
- Auxological evaluation_2 [Time frame: 3 years]
- Auxological evaluation_3 [Time frame: 3 years]
- Evaluation of the blood pressure [Time frame: 3 years]
- Evaluation of waist circumference [Time frame: 3 years]
- Evaluation of clinical signs of puberty (Tanner stage) and androgenism [Time frame: 3 years]
- Metabolic evaluation_1 [Time frame: 3 years]
- Metabolic evaluation_2 [Time frame: 3 years]
- Metabolic evaluation_3 [Time frame: 3 years]
- Metabolic evaluation_4 [Time frame: 3 years]
Secondary outcome measures (2)
- comparison with patients under weekly LAGH [Time frame: 3 years]
- Stratification of the metabolic profile of the patients according to IGF-1 levels [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Diagnosed with growth hormone deficiency (GHD)
- Treated with growth hormone (rhGH or LAGH)
Exclusion criteria
- No exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07173036 · 2025/02JUI/216