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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Styliani Giza, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01276743
First received: January 12, 2011
Last updated: February 27, 2014
Last verified: February 2014

January 12, 2011
February 27, 2014
February 2010
July 2011   (final data collection date for primary outcome measure)
• Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01276743 on ClinicalTrials.gov Archive Site
  • • 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 ]
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

whole blood

Non-Probability Sample

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

Type 1 Diabetes Mellitus
Not Provided
  • T1DM
    Children and adolescents with T1DM
  • Unaffected Population
    Population not known to be affected by T1DM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
February 2013
July 2011   (final data collection date for primary outcome measure)

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

Both
3 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01276743
01051979
Yes
Styliani Giza, Aristotle University Of Thessaloniki
Aristotle University Of Thessaloniki
Not Provided
Study Chair: Assimina Galli-Tsinopoulou, MD, PhD Aristotle University Of Thessaloniki
Aristotle University Of Thessaloniki
February 2014

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