More Favorable Metabolic Impact of Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Oral disposition index
研究概览
简要总结
Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is often not complied. The auxological effect of three injections per week (TIW) regimen is controversial, while the metabolic effects were never evaluated in children. The objective of this study was to evaluate whether two different regimens of weekly injections could lead to similar auxological and metabolic effects in children with GHD.
详细描述
Thirty-two children with growth hormone (GH) deficiency (25 males, mean age 10.5 ± 2.2 yr) were randomly assigned to receive daily (group A, No 16) or three injections per week (group B, No 16) GH therapy for 12 months.
Auxological parameters, insulin-like growth factor-I (IGF-I), glucose and insulin during an oral glucose tolerance test, glycosylated hemoglobin, lipid profile, the oral disposition index (DIo), the homeostasis model assessment estimate of insulin resistance (Homa-IR), the quantitative insulin sensitivity check index (QUICKI) and the insulin sensitivity index (ISI) were evaluated in the two groups of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Growth hormone deficiency clinically and biochemically demonstrated
排除标准
- •Children affected by multiple pituitary hormone deficiency or receiving any other kind of hormonal replacement therapy or drug and GHD children with a shorter follow-up
研究组 & 干预措施
group A
Sixteen growth hormone (GH) deficiency children were assigned to receive daily growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.
干预措施: Growth Hormone (Drug)
group B
Sixteen growth hormone (GH) deficiency children were assigned to receive three time weekly growth hormone therapy for 12 months. The investigators used an initial weekly dose of 0.175 mg/kg (corresponding to the daily dose of 0.025 mg/Kg) of GH with a gradual increase every 6 months in order to always maintain the insulin growth factor (IGF)-I levels in the normal range. In detail, from months 1 to 6 the investigators used the mean weekly dose of 0.175 mg/kg and from months 6 to 12 the mean weekly dose of 0.20 mg/kg.
干预措施: Growth Hormone (Drug)
结局指标
主要结局
Oral disposition index
时间窗: 12 months
Oral Disposition Index (DIo)
LDL cholesterol
时间窗: 12 months
Low Density Lipoprotein cholesterol (mmol/l)
Triglycerides
时间窗: 12 months
triglycerides (mmol/l)
height
时间窗: 12 months
height (standard deviation)
Insulin growth factor-I
时间窗: 12 months
insulin growth factor (IGF)-I (ug/L)
glucose
时间窗: 12 months
glucose (mmol/l) during oral glucose tolerance test
insulin
时间窗: 12 months
insulin (uU/ml) during oral glucose tolerance test
ISI Matsuda
时间窗: 12 months
Insulin Sensitivity Index
Homa IR
时间窗: 12 months
The homeostatic model assessment of insulin resistance
weight
时间窗: 12 months
weight (kilograms)
body mass index
时间窗: 12 months
body mass index (kilograms/m2)
glycated hemoglobin
时间窗: 12 months
glycated hemoglobin (%)
次要结局
未报告次要终点
研究者
Carla Giordano
Professor
University of Palermo