NCT01276743已完成不适用
Study of Protein Tyrosine Phosphatase Non-receptor Type 22 (PTPN22) C1858T Polymorphism in Children and Adolescents of Greek Origin With Type 1 Diabetes Mellitus (T1DM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- • Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin
研究概览
简要总结
The protein tyrosine phosphatase non-receptor type 22 (PTPN22) gene encodes a lymphoid-specific phosphatase (LYP) which is an important downregulatory factor of T cell activation. A PTPN22 polymorphism, C1858T, was found associated with T1DM in different Caucasian populations.
In this observational case-control study, we aimed at confirming the role of PTPN22, C1858T polymorphism in T1DM predisposition in a Greek population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the patients
- •Diagnosis of T1DM according to American Diabetes Association (ADA) Criteria as well as according to International Society for Pediatric and Adolescent Diabetes (ISPAD) Guidelines
- •Unrelated male and female subjects
- •1-20 years of age
- •Come from Greece (At least 3 grandparents are Greek)
- •At least one year post onset of T1DM
- •Sign written informed consent
- •Inclusion Criteria:
- •For the controls
- •Unrelated nondiabetic male and female subjects with no family history of T1DM
- •Equal to or greater than 18 years of age
- •Come from Greece (At least 3 grandparents are Greek)
- •Be screened by a questionnaire to ensure the absence of any diagnostic evidence of autoimmune diseases or family history (first- or second-degree relatives) of T1DM
- •Sign written informed consent
排除标准
- •For the patients •Subjects who do not meet the criteria above
- •Exclusion Criteria:
- •For the controls
- •Subjects who do not meet the criteria above
结局指标
主要结局
• Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin
时间窗: 3 years
次要结局
- • The association between PTPN22 C1858T polymorphism among patients and gender(3 years)
- • The association between the PTPN22 C1858T polymorphism among patients and presence of autoantibodies(3 years)
- • The association between PTPN22 C1858T polymorphism among patients and age of onset of type 1 diabetes mellitus (T1DM)(3 years)
研究者
Styliani Giza
MD, MSc, PhD, 4th Department of Pediatrics, Faculty of Medicine, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece
Aristotle University Of Thessaloniki
研究点 (1)
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