Study of PTPN22 C1858T Polymorphism in Children and Adolescents of Greek Origin With T1DM

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT01276743
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2011-07
• Study Completion: 2013-02
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

For the patients •Subjects who do not meet the criteria above

Exclusion Criteria:

For the controls

•Subjects who do not meet the criteria above

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin	3 years

Secondary Outcome Measures

Name	Time	Method
• 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

Trial Locations

Locations (1)

Unit of Pediatric Endocrinology, Diabetes and Metabolism, 4th Department of Pediatrics, Medical School, Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece