Metabolomics of Thyroid Hormones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- Metabolome signature of thyroid Hormone Status (MSTH)
研究概览
简要总结
The aim of this study is to develop a metabolome signature of thyroid hormone status. The metabolome signature could be useful in diagnosis and treatment of thyroid dysfunction diseases, especially in cases where TSH cannot be reliably used.
详细描述
Primary Hypothyroidism is a frequent endocrine disorder, where the thyroid gland does not produce sufficient amounts of thyroid hormones. The substitution therapy is guided by measurement of the pituitary gland hormone thyrotropin (TSH). Patients with central hypothyroidism in whom pituitary insufficiency leads to hypothyroidism, TSH cannot be used to guide therapy. So far there are no reliable methods for therapy control in patients with central hypothyroidism.
The measurement of small endogenous metabolites might give investigators a metabolomics profile. This could help to discriminate between euthyroid, hypothyroid and hyperthyroid state and therefore could be used for diagnosis and therapy control of thyroid dysfunction diseases.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants:
- •Age 18 to 80 years
- •BMI 19 to 35 kg/m2
- •Informed consent as documented by signature
- •A) Patients with primary hyperthyroidism TSH < 0.2 mIU/l and free thyroxine (fT4) > 25 pM or fT3 > 8 pM
- •B) Patients with primary hypothyroidism, currently not sufficiently substituted TSH > 8 milli-International unit (mIU)/l or fT4 < 10 pM
- •C) Patients with diagnosis of primary hypothyroidism, sufficiently substituted Documented diagnosis of primary hypothyroidism Substitution with L-Thyroxin TSH in target range between 0.5 and 2.5 mIU/l
- •D) Patients with secondary hypothyroidism Pituitary disease with documented secondary hypothyroidism
排除标准
- •Diabetes mellitus (HbA1c >6.5%)
- •Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
- •Abuse of alcohol or illicit drugs
- •Women who are pregnant or breast feeding
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Previous enrolment into the current study
结局指标
主要结局
Metabolome signature of thyroid Hormone Status (MSTH)
时间窗: baseline/single visit
The MSTH will be tested against the current standard of diagnosis which is serum TSH level by multiple linear regression.
次要结局
- Resting energy expenditure (REE)(baseline/single visit)
- Body composition concerning fat mass(baseline/single visit)
- Body composition concerning muscle mass(baseline/single visit)