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

NCT ID: NCT01276743

Last Updated: 2014-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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T1DM

Children and adolescents with T1DM

No interventions assigned to this group

Unaffected Population

Population not known to be affected by T1DM

No interventions assigned to this group

Eligibility Criteria

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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


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


For the controls

•Subjects who do not meet the criteria above
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Styliani Giza

MD, MSc, PhD, 4th Department of Pediatrics, Faculty of Medicine, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Assimina Galli-Tsinopoulou, MD, PhD

Role: STUDY_CHAIR

Aristotle University Of Thessaloniki

Locations

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

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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01051979

Identifier Type: -

Identifier Source: org_study_id

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