Type 2 Deiodinase Gene Polymorphism and the Treatment of Hypothyroidism Caused
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- TSH suppression
研究概览
简要总结
This project analyzes the relationship between type 2 deiodinase gene polymorphism and the TSH inhibitory treatment efficacy in thyroid cancer patients with thyroidectomy, and explored the factors influencing TSH inhibitory treatment efficacy. It further explores whether patients with diO2-Thr92ALA genotype or DIO2 Orfa-Gly3ASP genotype should choose T4+T3 treatment, and the effect of different treatment options on the quality life of patients.
详细描述
Object: To explore the relationship between type 2 deiodinase gene polymorphism and the TSH inhibitory treatment efficacy in thyroid cancer patients with thyroidectomy, And figure out if it is better for patients with diO2-Thr92ALA genotype or DIO2 Orfa-Gly3ASP genotype to choose T4+T3 treatment,
Design:
Part I: Analysis of the correlation between DIO2 genotype and TSH inhibitory treatment effect:
- In accordance with inclusion and exclusion criteria; A total of 100 patients undergoing total thyroidectomy for thyroid cancer and 100 patients receiving 131 iodine treatment after total thyroidectomy will be included in our hospital from October 2021 to October 2022. All the patients signed informed consent
- Detection of basic condition:
The included patients were recorded with height, weight, BMI, routine biochemistry, homocysteine, thyroid function, thyroid peroxidase antibodies, thyroglobulin, thyroid globulin, 3. Genotype detection of DIO2 gene RS225014 and RS12885300 loci were tested for all the patients. 4. Regular L-T4 treatment and drug dose adjustment:
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Hypothyroidism after total thyroidectomy for papillary thyroid carcinoma
- •Patients were informed of the study and voluntarily willing to participate.
排除标准
- •Having depression or other mental illness
- •Taking drugs that interfere with thyroid hormone absorption for other chronic diseases
- •impaired liver function, defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
- •impaired renal function ,eGFR: <45 mL/min (calculated by MDRD formula)
- •Recent Cardiovascular Events in a patient:
- •(1)Acute Coronary Syndrome (ACS) within 2 months prior to enrolment (2).Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment (3)Acute Stroke or TIA within two months prior to enrolment (4)Less than two months post coronary artery revascularization
- •Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure.
- •Pregnant or breastfeeding women
研究组 & 干预措施
L-T4 therapy group
Patients with refractory hypothyroidism still receive L-T4 therapy as usual.
干预措施: L-T4 (Drug)
L-T4+T3 therapy group
Patients with refractory hypothyroidism receive L-T4+T3 therapy
干预措施: L-T4+T3 (thyroid tablet) (Drug)
结局指标
主要结局
TSH suppression
时间窗: Up to 6 months
The TSH level can reach the aim of the TSH suppresion therapy
次要结局
- quality life evalutaion(Up to 6 months)