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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Auxological evaluation_1 [Срок оценки: 3 years]
• Auxological evaluation_2 [Срок оценки: 3 years]
• Auxological evaluation_3 [Срок оценки: 3 years]
• Evaluation of the blood pressure [Срок оценки: 3 years]
• Evaluation of waist circumference [Срок оценки: 3 years]
• Evaluation of clinical signs of puberty (Tanner stage) and androgenism [Срок оценки: 3 years]
• Metabolic evaluation_1 [Срок оценки: 3 years]
• Metabolic evaluation_2 [Срок оценки: 3 years]
• Metabolic evaluation_3 [Срок оценки: 3 years]
• Metabolic evaluation_4 [Срок оценки: 3 years]

Вторичные конечные точки (2)

• comparison with patients under weekly LAGH [Срок оценки: 3 years]
• Stratification of the metabolic profile of the patients according to IGF-1 levels [Срок оценки: 3 years]

Критерии участия

Критерии включения

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

Критерии исключения

• No exclusion criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07173036 · 2025/02JUI/216

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗