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
  Purpose

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.


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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)

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

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

Secondary Outcome Measures:
  • • 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 ]

Biospecimen Retention:   Samples With DNA

whole blood


Enrollment: 200
Study Start Date: February 2010
Study Completion Date: February 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
T1DM
Children and adolescents with T1DM
Unaffected Population
Population not known to be affected by T1DM

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276743

Locations
Greece
Unit of Pediatric Endocrinology, Diabetes and Metabolism, 4th Department of Pediatrics, Medical School, Aristotle University of Thessaloniki
Thessaloniki, Greece, 54603
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Study Chair: Assimina Galli-Tsinopoulou, MD, PhD Aristotle University Of Thessaloniki
  More Information

Additional Information:
No publications provided

Responsible Party: Styliani Giza, MD, MSc, PhD, 4th Department of Pediatrics, Faculty of Medicine, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01276743     History of Changes
Other Study ID Numbers: 01051979
Study First Received: January 12, 2011
Last Updated: February 27, 2014
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014