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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by Aristotle University Of Thessaloniki.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Aristotle University Of Thessaloniki

ClinicalTrials.gov Identifier:

NCT01276743

First received: January 12, 2011

Last updated: NA

Last verified: February 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

January 12, 2011

Last Updated Date

January 12, 2011

Start Date ^ICMJE

February 2010

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

• Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

• The association between PTPN22 C1858T polymorphism among patients and gender [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• The association between PTPN22 C1858T polymorphism among patients and age of onset of type 1 diabetes mellitus (T1DM) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• The association between the PTPN22 C1858T polymorphism among patients and presence of autoantibodies [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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 Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

whole blood

Sampling Method

Non-Probability Sample

Study Population

Children and adolescents of Greek origin who attended the Pediatric Diabetes Outpatient Clinic of 4th Department of Pediatrics of Medical School of Aristotle University of Thessaloniki for T1DM

Condition ^ICMJE

Type 1 Diabetes Mellitus

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

T1DM
Children and adolescents with T1DM
Unaffected Population
Population not known to be affected by T1DM

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

February 2013

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

3 Years to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Assimina Galli-Tsinopoulou, MD, PhD	+302310991537	assimina@med.auth.gr
Contact: Styliani Giza, MD, MSc	+302310991537	stellagiza@yahoo.com

Location Countries ^ICMJE

Greece

Administrative Information

NCT Number ^ICMJE

NCT01276743

Other Study ID Numbers ^ICMJE

01051979

Has Data Monitoring Committee

Yes

Responsible Party

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

Study Sponsor ^ICMJE

Aristotle University Of Thessaloniki

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Assimina Galli-Tsinopoulou, MD, PhD

Aristotle University Of Thessaloniki

Information Provided By

Aristotle University Of Thessaloniki

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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