Recombinant Human Growth Hormone (GH): Effects on Metabolic Profile, Body Composition and Skeletal Muscle Strength and Function in Pre-pubertal Short Boys With and Without GH Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Skeletal muscle strength (Newtons)
研究概览
简要总结
The purpose of the study is to measure the functional effects of recombinant GH in skeletal muscle, in addition to growth promotion, in short prepubertal boys with either growth hormone deficiency or idiopathic short stature. Patients will be similarly short. The investigators will also compare these values in the short stature cohort to those obtained in testing performed in normally growing age-matched healthy control boys not on GH. The group on GH will be studied before and after 6 and 12 months of GH treatment.
详细描述
Prepubertal boys with significant short stature (height SDS ≤-2.0) diagnosed with either GH deficiency or idiopathic short stature (ISS) who are identified as candidates for GH treatment will recruited. Subjects will have a battery of studies to assess skeletal muscle strength, agility, power and endurance, as well as assessment of body composition and energy expenditure before and after GH administration. GH (Somatropin) treatment at standard doses will be given as daily injections at bedtime. Subjects will be followed at three-month intervals per the clinical routine, when anthropometric measurements will be obtained. Baseline studies will be repeated at 6 and 12 months from initiation of treatment, each patient will serve as his own control pre and post GH.
A group of normally statured healthy boys will have the same testing as the study patients but without GH treatment to assess the impact of natural growth on the muscle measures above.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Short Stature Group
- •30 boys between 6-11 years of age
- •Prepubertal
- •Short stature (height ≤ -2SDS) due to either GH deficiency or idiopathic
- •Stable treatment of other pituitary hormone deficiencies
- •Naïve to GH therapy, or GH discontinued at least 6 months prior to study
- •Normal Stature Group
- •15 boys between 6-11 years of age
- •Prepubertal
- •Normal height (10th to 90th%)
排除标准
- •Actively growing brain tumors
- •Chronic medical conditions that could affect study outcomes
- •Long-term steroid use
- •Intense regular physical training programs or organized team sports
研究组 & 干预措施
Short Stature Boys
Prepubertal boys with short stature defined as a height ≤-2 SDS with either GH deficiency (defined as peak GH responses to pharmacologic stimuli <10ng/ml) or idiopathic short stature (i.e., no identifiable pathology) will be studied pre and post 12 months of GH therapy.
干预措施: Somatropin injection (Drug)
结局指标
主要结局
Skeletal muscle strength (Newtons)
时间窗: 12 months
Upper and lower body muscle strength will be assessed using a handheld dynamometer for manual muscle testing of peak force
次要结局
- Muscle endurance(12 months)
- Lean body mass accrual(12 months)
- Skeletal muscle power (Watts)(12 months)
- Muscle agility (seconds)(12 months)
- Resting energy expenditure(12 months)
- Bone mineral density(12 months)
研究者
Nelly Mauras
MD
Nemours Children's Clinic