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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Radiological evaluation of cIMT
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with growth hormone deficiency (GHD)
- •Treated with growth hormone (rhGH or LAGH)
排除标准
- •No exclusion criteria
研究组 & 干预措施
rhGH cohort
Patients with GHD who receive daily rhGH (dose titration according to guidelines i.e. 25-35 micrograms/kg body weight/day)
干预措施: metabolic and auxological outcomes (Other)
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)
干预措施: metabolic and auxological outcomes (Other)
结局指标
主要结局
Radiological evaluation of cIMT
时间窗: 3 years
Measurements of cIMT (mm) using Doppler ultrasound.
Endothelial stress and inflammatory markers_3
时间窗: 3 years
Measurements in blood samples of endothelial stress and inflammatory markers such as VEGF (pg/mL).
Endothelial stress and inflammatory markers_4
时间窗: 3 years
Measurements in blood samples of endothelial stress and inflammatory markers such as IL-6 (pg/mL).
Auxological evaluation_1
时间窗: 3 years
Primary outcome measures included change in stature (in cm and SDS) over the course of the study.
Auxological evaluation_2
时间窗: 3 years
Primary outcome measures included change in weight (in kgs and SDS) over the course of the study.
Auxological evaluation_3
时间窗: 3 years
Primary outcome measures included change in BMI (in kg/m2) over the course of the study.
Evaluation of the blood pressure
时间窗: 3 years
Measure of the systolic and diastolic blood pressure (in mmHg) with a sphygmomanometer
Evaluation of waist circumference
时间窗: 3 years
Measure of waist circumference (in cm) with a meter
Evaluation of clinical signs of puberty (Tanner stage) and androgenism
时间窗: 3 years
Evaluation of clinical signs of puberty (Tanner stage) and androgenism.
Metabolic evaluation_1
时间窗: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting glycemia (mg/dl).
Metabolic evaluation_2
时间窗: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of fasting insulin (pmol/L).
Metabolic evaluation_3
时间窗: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of hemoglobin A1c in diabetic patients (%).
Metabolic evaluation_4
时间窗: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of transaminases (UI/L).
Metabolic evaluation_5
时间窗: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of lipid profile (mg/dL).
Metabolic evaluation_6
时间窗: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of creatinine (mg/dL).
Metabolic evaluation_7
时间窗: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of alkaline phosphatase (UI/L).
Metabolic evaluation_8
时间窗: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of calcium (mmol/L).
Metabolic evaluation_9
时间窗: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of phosphorus (mmol/L).
Metabolic evaluation_10
时间窗: 3 years
Evaluation of the change of the metabolic profile using both SOC and non-SOC Blood tests samples. Measurements of insulin-like growth factor 1 levels (ng/mL).
Bone markers_1
时间窗: 3 years
Measurements in blood samples of bone markers such as procollagen type 1 N-terminal propeptide (µg/L).
Bone markers_2
时间窗: 3 years
Measurements in blood samples of bone markers such as insulin-like growth factor (ng/mL).
Bone markers_3
时间窗: 3 years
Measurements in blood samples of bone markers such as insulin-like growth factor binding protein (µL/mL).
Endothelial stress and inflammatory markers_1
时间窗: 3 years
Measurements in blood samples of endothelial stress and inflammatory markers such as asymmetric dimethylarginine (µmol/L).
Endothelial stress and inflammatory markers_2
时间窗: 3 years
Measurements in blood samples of endothelial stress and inflammatory markers such as TNF-a (pg/mL).
Radiological evaluation of body fat distribution
时间窗: 3 years
Measurements of body fat distribution (g/cm2) using DEXA-Scan.
次要结局
- comparison with patients under weekly LAGH(3 years)
- Stratification of the metabolic profile of the patients according to IGF-1 levels(3 years)