Rate of Recovery of Secondary Hypothyroidism in Patients With Pituitary Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving euthyroid status
研究概览
简要总结
The aim of this project is to assess the rate of recovery of secondary hypothyroidism in patients with pituitary disorders.
详细描述
The study will be conducted in three stages.
Stage 1 ( Patient identification and enrollment)
We will generate a list of all SHT patients from the HNP database and all patients will be contacted by the principal investigator (or their designate) regarding the study. Those patients who agree to participate in the study will be given a written consent form. We aim to enrol approximately 90 -100 patients for the study. Laboratory samples for serum TSH and T4 levels will be collected to confirm that all patients are adequately replaced for SHT. Those patients who are not adequately replaced and have low T4 will be excluded from the study.
Stage 2 (T4 withdrawal protocol)
Stepwise T4 replacement therapy will be initiated as follows.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of secondary hypothyroidism who are currently taking T4 replacement therapy
排除标准
- •uncontrolled cardiovascular disease
- •uncontrolled congestive heart failure
- •uncontrolled mental health disorder
- •not adequately replaced and have low T4 level.
结局指标
主要结局
Percentage of patients achieving euthyroid status
时间窗: 12 weeks
Percentage of patients able to maintain normal TSH/T4 without thyroxine replacment
次要结局
未报告次要终点