NCT03498417已完成不适用
Serum Antibodies Against the Insulin-like Growth Factor-1 Receptor (IGF-1R) in Graves' Disease and Graves' Orbitopathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Frequency of serum IGF-1R-Abs above the upper normal levels
研究概览
简要总结
The study is aimed at assessing IGF-1R-Abs in patients with Graves' disease, with or without GO, compared with healthy subjects and patients with autoimmune thyroiditis in a cross-sectional investigation.
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
- 是
入选标准
- •for Graves' disease: a history of hyperthyroidism, associated with previous or present detectable serum autoantibodies against the TSH-R;
- •for autoimmune thyroiditis: the presence of at least two of the following: a) primary hypothyroidism; b) detectable serum autoantibodies against thyroglobulin or thyroperoxidase ; c) a hypoechoic pattern of the thyroid by ultrasound examination.
- •for healthy subjects: absence of any clinical, biochemical or instrumental evidence of thyroid diseases.
- •For all subjects: Informed consent
排除标准
- •lack of informed consent
结局指标
主要结局
Frequency of serum IGF-1R-Abs above the upper normal levels
时间窗: Baseline
Percent prevalence of serum IGF-1R-Abs above the upper normal levels in patients with GO, compared with healthy subjects, patients with Graves' disease without a clinically relevant GO, and patients with autoimmune thyroiditis.
次要结局
- Relationship between serum IGF-1R-Abs and anti-thyroglobulin autoantibodies(Baseline)
- Serum concentrations of IGF-1R-Abs(Baseline)
- Relationship between serum IGF-1R-Abs and anti-TSH receptor autoantibodies(Baseline)
- Relationship between serum IGF-1R-Abs and the activity of GO(Baseline)
- Relationship between serum IGF-1R-Abs and anti-thyroperoxidase autoantibodies(Baseline)
研究者
Marinò Michele
Assistant Professor
University of Pisa
研究点 (1)
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