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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276743
• Other study ID #: 01051979
• Status: Completed
• Phase: N/A
• First received: January 12, 2011
• Last updated: February 27, 2014
• Start date: February 2010
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
Greece	Unit of Pediatric Endocrinology, Diabetes and Metabolism, 4th Department of Pediatrics, Medical School, Aristotle University of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin		3 years	No
Secondary	• The association between PTPN22 C1858T polymorphism among patients and gender		3 years	No
Secondary	• The association between PTPN22 C1858T polymorphism among patients and age of onset of type 1 diabetes mellitus (T1DM)		3 years	No
Secondary	• The association between the PTPN22 C1858T polymorphism among patients and presence of autoantibodies		3 years	No

External Links

•   Published as a clinical study in 2013 in the international journal BioMed Research International with the most recent Impact Factor 2.880 according to 2012 Journal Citation Reports released by Thomson Reuters (ISI) in 2013