Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Body composition: fat mass and lean body mass
研究概览
简要总结
Growth hormone treatment is used in girls with Turner syndrome to increase final height. The aim of this study is to evaluate the effect of growth hormone treatment on body composition and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass will decrease and lean body mass will increase. There is only very limited documentation of the effect on the heart in this study population.
详细描述
This study is a randomised, double-blinded, controlled clinical trial to evaluate the effect of growth hormone (GH) treatment on adult women with Turner syndrome. The endpoints will be changes in body composition and heart function evaluated by echocardiography (ECHO) and positron emission tomography (PET).
Phase one: 6 months of GH or placebo treatment. Phase two: "open label" all participants are treated with GH for 12 months. At baseline, healthy controls will be examined, but will not receive any treatment
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Turner syndrome
- •Age 20-40
排除标准
- •Symptomatic heart disease
- •Anti hypertensive treatment
- •Untreated thyroid disease
- •Adipositas (BMI > 35)
- •Treatment with glucocorticoids
- •Pregnancy
研究组 & 干预措施
A1
干预措施: Growth Hormone (Drug)
A2
干预措施: Placebo (Drug)
A3
干预措施: Healthy controls (Other)
结局指标
主要结局
Body composition: fat mass and lean body mass
时间窗: 6 months + 18 months
Myocardial perfusion and glucose uptake, evaluated by positron emission tomography
时间窗: 6 months
次要结局
- Heart function evaluated by echocardiography (conventional and tissue doppler)(6 months + 18 months)
- Lipid profile(6 months + 18 months)
- 24 hour ambulatory blood pressure(6 months + 18 months)
研究者
Britta E. Hjerrild
MD PhD Clinical assistent
University of Aarhus