Characteristics of Islet β-cell Functions in Chinese Patients With Graves' Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 主要终点
- change from baseline blood glucose at 6 months
研究概览
简要总结
Patients with GD often present with glucose dysregulation, which, according to most studies, is associated with islet β-cell dysfunctions, enhanced gluconeogenesis and insulin resistance (IR). Current studies focus mainly on IR, and a few that investigate islet β-cell functions show inconsistent results. This study examined the characteristics of glucose dysregulation in Chinese patients with GD, and furthermore evaluated the effects of thyroid dysfunction on islet β-cell functions and subsequently the carbohydrate metabolism.
详细描述
Thyroid dysfunction is closely associated with glucoregulation. Carbohydrate metabolism can be affected with decreased levels of thyroid hormone (TH), even more so with an elevated TH level. Epidemiological data shows that 2%-57% of patients with Graves' Disease (GD) present with glucose dysregulation, which might also be related to the changes in islet β-cell functions in patients with GD. The incidence of GD has comparable variations geographically, with possibly different underlying mechanisms, such as an excessive intake of iodine resulting in an aggravation of autoimmune reactions from thyroid and consequently an increment in incidence of GD. The same might also be true in glucoregulation and islet β-cell functions in patients with GD. This study aims to examine the characteristics of glucoregulation and islet β-cell functions in patients with GD in different areas of China, using early-phase insulin secretion index (△I30/△G30), glucose area under curve(GAUC) and insulin area under curve(INSAUC).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Graves Disease
- •Age-matched healthy checkup subjects
排除标准
- •Patients with a medical history of diabetes, pancreatitis and other related conditions and positive family histories as well as medication history of glucocorticoid and anti-diabetic agents
研究组 & 干预措施
GA1
subjects from coastal areas who initiated Methimazole treatment for the first time on enrollment
干预措施: Methimazole (Drug)
GA2
subjects from coastal areas who were under Methimazole treatment and with an elevated TH level
干预措施: Methimazole (Drug)
GA3
subjects from coastal areas who were under Methimazole treatment and with a normal TH level
干预措施: Methimazole (Drug)
GB1
subjects from non-coastal areas who initiated Methimazole treatment for the first time on enrollment
干预措施: Methimazole (Drug)
GB2
subjects from non-coastal areas who were under Methimazole treatment and with an elevated TH level
干预措施: Methimazole (Drug)
GB3
subjects from non-coastal areas who were under Methimazole treatment and with a normal TH level
干预措施: Methimazole (Drug)
结局指标
主要结局
change from baseline blood glucose at 6 months
时间窗: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment
change from baseline insulin at 6 months
时间窗: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment
change from baseline thyroid hormone at 6 months
时间窗: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment
change from baseline urine iodine concentration at 6 months
时间窗: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment
次要结局
未报告次要终点
研究者
Weikai Hou
Professor
Qilu Hospital of Shandong University