Longtime Effect of Combination Treatment With L-thyroxine (L-T4) and Liothyronine (L-T3) in Patients With Persistent Hypothyroid Symptoms - Relation to Polymorphisms (SNP) in the DIO2 and the MCT10 Gene
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Polymorphisms in DIO2/MCT10 and triiodothyronine treatment
研究概览
简要总结
Hypothesis: Variations in the deiodinase 2 gene and monocarboxylate transporter 10 gene is associated with improvement in quality of life after initiation of combination therapy with L-Thyroxine and Liothyronine in patients with persistent hypothyroid symptoms despite conventional L-thyroxine mono-therapy.
Purpose: To re-test this hypothesis in patients with continued perceived effect of Liothyronine treatment at least one year after initiation in a patient population more representing of daily clinical practice. The study will help determine whether testing of specific gene variations might predict longtime effect of combination therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- 否
入选标准
- •Patients admitted to the department of endocrinology with the diagnose hypothyroidism because of persistent hypothyroid symptoms despite treatment with L-thyroxine mono-therapy and normal and stable TSH (for at least 6 months).
- •Started in combination therapy with L-thyroxine and Liothyronine in an approximately 17/1 ratio
- •Exclusion of an alternative explanation for persistent hypothyroid symptoms
排除标准
- •Initiation of L-thyroxine treatment in patients with s-TSH below upper normal limit (with assay in current use, that is TSH < 4 mU/L)
- •Ongoing pregnancy
- •Age below 18 years or above 80 years.
- •Patients who do not read and understand information material given
- •Patients who are not competent to give informed consent
结局指标
主要结局
Polymorphisms in DIO2/MCT10 and triiodothyronine treatment
时间窗: Single assessment point, from 1-10 years after initiation of combination therapy
Group 1(responders) and group 2(non-responders) are compared with regard to polymorphisms in the DIO2 gene and the MCT10 gene. Polymorphisms will be determined from DNA in a blood sample
次要结局
- Who controls the treatment?(Single assessment point, from 1-10 years after initiation of combination therapy)
- Risk of arrhythmia(Single assessment point, from 1-10 years after initiation of combination therapy)
- Quality of life questionnaire(Single assessment point, from 1-10 years after initiation of combination therapy)
- Osteoporosis(Single assessment point, from 1-10 years after initiation of combination therapy)
- Proportion treated with triiodothyronine(Single assessment point, from 1-10 years after initiation of combination therapy)
- How is current treatment controlled?(Single assessment point, from 1-10 years after initiation of combination therapy)
- Have therapy changed after the patient left the department of endocrinology?(Single assessment point, from 1-10 years after initiation of combination therapy)
- TSH(Single assessment point, from 1-10 years after initiation of combination therapy)
研究者
Birte Nygaard
Chief Physician, Ph.D
Herlev Hospital