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NCT Number: NCT01276743

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

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Thessaloniki, 54603, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. • Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin

    Time frame: 3 years

Secondary outcomes

  1. • The association between PTPN22 C1858T polymorphism among patients and gender

    Time frame: 3 years

  2. • The association between PTPN22 C1858T polymorphism among patients and age of onset of type 1 diabetes mellitus (T1DM)

    Time frame: 3 years

  3. • The association between the PTPN22 C1858T polymorphism among patients and presence of autoantibodies

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Jan 13, 2011
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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