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临床试验/NCT01744769
NCT01744769Unknown不适用

Effects of Thyroid Hormone Withdrawal on Metabolic and Cardiovascular Parameters During Radioactive Iodine Therapy in Differentiated Thyroid Cancer

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Changes of metabolic parameters

研究概览

简要总结

  1. The incidence of differentiated thyroid cancer is increasing in Korea. A significant number of them experience severe hypothyroidism in preparation for radioactive iodine (RAI) therapy after total thyroidectomy.
  2. Because the function of thyroid hormone is closely linked with lipid and glucose metabolism, overt hypothyroidism after thyroid hormone withdrawal during RAI therapy may induce the changes of metabolic parameters.
  3. We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular parameters during radioactive iodine therapy in differentiated thyroid cancer.

详细描述

  1. Study design measurement of various parameters during hypothyroid state (before 1 month, the day and after 1 month of RAI therapy)

  2. Measurements

  3. Measurement of metabolic and cardiovascular parameters

  • glucose profiles : HbA1c, fasting glucose level
  • lipid profiles : free fatty acid, total, LDL-, HDL-, cholesterol, triglyceride
  • adipocytokines : retinol binding protein(RBP)
  • 4, leptin, resistin, adiponectin
  • markers of endothelial and cardiac function : high-sensitivity C-reactive protein(hsCRP), homocystein, B-type natriuretic peptide(BNP)
  • bone turnover markers : CTX, bone ALP
  1. Scoring of symptoms and signs of hypothyroidism (Zulewski score)
  • symptoms
  • physical signs

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • radioiodine therapy after total thyroidectomy in differentiated thyroid cancer
  • age over 18

排除标准

  • kidney failure, liver failure, heart failure
  • infection
  • inflammation
  • autoimmune disease
  • other chronic disease

结局指标

主要结局

Changes of metabolic parameters

时间窗: Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine therapy

* glucose profiles : HbA1c, fasting glucose level * lipid profiles : free fatty acid, total, LDL-, HDL-, cholesterol, triglyceride * adipocytokines : retinol binding protein(RBP)4, leptin, resistin, adiponectin * markers of endothelial and cardiac function : high-sensitivity C-reactive - protein(hsCRP), homocystein, B-type natriuretic peptide(BNP)

次要结局

  • Changes of bone turnover markers(Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine terapy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suk Kyeong Kim

Associate professor

Konkuk University Medical Center

研究点 (1)

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