NCT01351818已完成不适用
The Fayds Project: Adipocyte Function and Somtropin Deficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion
研究概览
简要总结
To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency.
Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a regulatory effect on such hormones.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of both sexes aged from 5 to 12 years, Tanner stage 1, with no signs of imminent pubertal development. Amenable to treatment with recombinant somatropin in the approved indication of low growth due to GH deficiency
- •Selection of recombinant somatropin by the physician in the treatment authorization request, and subsequent approval of such treatment by the relevant growth hormone committee
- •Body Mass Index (BMI) within ±1 SD
排除标准
- •Children with any of the reported contraindications for treatment with recombinant somatropin, existence of active neoplasms, progression or recurrence of intracranial lesion, etc. will not be studied
- •Diabetes mellitus
- •Intestinal inflammatory disease
- •Celiac disease
- •Uncontrolled hyperthyroidism
- •Other diseases causing chronic malabsorption, hypercatabolism or malnutrition conditions
- •Chronic liver disease
- •Eating disorders: anorexia, bulimia, etc
- •Long-term treatment with anti-obesity drugs or drugs causing malabsorption
研究组 & 干预措施
Growth hormone
Patients with a condition
干预措施: Growth Hormone (Drug)
结局指标
主要结局
To evaluate the potential influence of exogenous GH administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion
时间窗: 1 year
次要结局
- Height assessment (using Harpenden stadiometer)(1 year)
- Weight assessment(1 year)
- BMI assessment(1 year)
研究者
研究点 (1)
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