Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 6
研究概览
简要总结
Hypopituitary adults with all the hormonal deficiencies are well subsituted excepted for the growth hormone (GH) and died earlier than the rest of the population. GH deficiency involves a fat mass increase with regard to lean mass, an atherogenic lipidic profile and participating to osteopenia mechanism and decrease the life quality. All these dysfunctions are partially or totally corrected by the GH prescription with patient deficient since adulthood.
However, for patients deficient since childhood, no study have demonstrated that GH treatment during childhood present these same benefit when they are treated during adulthood.
Primary objective of this study is to examine that fat mass significantly decrease due to GH treatment in adulthood for patient GH deficient since childhood, treated by GH during childhood but stopped since the end of adolescence.
We compare the body composition and others energetic metabolism parameters in two patient groups, one treated by GH during 18 months, and the other with no treatment. Body composition and bone density are measured by pletysmography (DEXA). Metabolic parameters are : energetic balance (energy intake evaluation by questionnaire, energetic expenditure evaluated by doubly labelled water) and biologic parameters (lipidic profile, thyroid hormones).
This study will evaluate if the GH treatment of young GH deficient adults since childhood can be a benefit for body composition, lipidic profile and bone density.
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age > 18-35 years)
- •Stable body mass +/- 5 kg in 3 months
- •GH deficiency since childhood, treated by GH during childhood, having stopped GH treatment at the end of adolescence
- •Want to receive again GH treatment or refusing new GH treatment
- •GH deficiency confirmed at adulthood by GHRH-Arginine test
- •Women receiving GH treatment must have a efficient contraceptive method
- •Have given a writing informed consent
排除标准
- •Somatotropic insufficiency
- •All pathologies or treatment modifing energetic metabolism, excepted diabet mellitus and obesity
- •Participating to another clinical trial during the three months befor inclusion
- •Pathologies modifing bone metabolism
- •Pregnancy/Feeding
- •Refusal to consent
