Elucidation of the Effects of Growth Hormone (GH) Deficiency and GH Replacement on Clot and Platelet
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Turbidity analysis.
研究概览
简要总结
Large population studies of hypopituitary adults (patients with pituitary gland failure) on conventional hormone replacement, but not growth hormone, have an approximate two fold increase in death rate (mortality). The vast majority of this excess mortality relates to vascular disease. While it is possible that overreplacement with steroids, underreplacement with thyroid hormones and sex hormone deficiency contribute, there are increasing data to support a role for GH in the cause of the excess vascular risk. Although a number of surrogates of vascular risk are described in patients with GH deficiency (GHD), how these translate mechanistically into atherothrombotic (blockage of the arteries) disease has not been fully elucidated.
This proposed study will analyse both traditional (body composition, serum lipids, handling of sugars)and more complex markers (inflammation, procoagulation, fibrinolysis) of vascular risk/disease. In addition the study will examine 24hr blood pressure, arterial wall thickness, clot structure and function, as well as platelet action. Measurements will be performed at baseline and will be reassessed after patients have been on a stable dose of GH replacement for at least three months.
The results of the study will characterise risk factors for vascular disease, and take this a step further to elucidate how these changes translate mechanistically in to vascular damage.
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
- 16 Years 至 90 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give written consent
- •Adults with confirmed GHD (Insulin stimulation test <3ug/L)
- •Other hormone replacement therapy stable for at least three months
排除标准
- •active malignancy
- •an acute vascular event within three months of the study
- •any therapy other than hormone replacement
- •serum creatinine >120 micromol/l
- •abnormal LFTs (ALT>3 fold upper limit of normal)
研究组 & 干预措施
Growth Hormone Therapy
干预措施: Growth Hormone Therapy (Drug)
结局指标
主要结局
Turbidity analysis.
时间窗: up to 3 years
次要结局
未报告次要终点
