Clinical trial NCT01276743: Study of PTPN22 C1858T Polymorphism in Children and Adolescents of Greek Origin With T1DM
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: • Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin
timeFrame: 3 years
Secondary outcomes:
measure: • The association between PTPN22 C1858T polymorphism among patients and gender
timeFrame: 3 years
measure: • The association between PTPN22 C1858T polymorphism among patients and age of onset of type 1 diabetes mellitus (T1DM)
timeFrame: 3 years
measure: • The association between the PTPN22 C1858T polymorphism among patients and presence of autoantibodies
timeFrame: 3 years
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Unit of Pediatric Endocrinology, Diabetes and Metabolism, 4th Department of Pediatrics, Medical School, Aristotle University of Thessaloniki
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Assimina Galli-Tsinopoulou, MD, PhD
role: STUDY_CHAIR
References: