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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01276743

Enrollment

200

Registered

2011-01-13

Start date

2010-02-28

Completion date

2013-02-28

Last updated

2014-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
• The association between PTPN22 C1858T polymorphism among patients and gender	3 years
• The association between PTPN22 C1858T polymorphism among patients and age of onset of type 1 diabetes mellitus (T1DM)	3 years
• The association between the PTPN22 C1858T polymorphism among patients and presence of autoantibodies	3 years

Countries

Greece

Outcome results