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

NCT01276743 | Completed DMC

• 1 other identifier: 01051979
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (3)

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

  3 years

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

  3 years

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

  3 years

Study Arms (2)

T1DM

Children and adolescents with T1DM

Unaffected Population

Population not known to be affected by T1DM

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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
• years of age
• Come from Greece (At least 3 grandparents are Greek)
• At least one year post onset of T1DM
• Sign written informed consent
• 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

You may not qualify if:

• For the patients •Subjects who do not meet the criteria above
• For the controls
• Subjects who do not meet the criteria above

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

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

Thessaloniki, 54603, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Assimina Galli-Tsinopoulou, MD, PhD

  Aristotle University Of Thessaloniki

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, PhD, 4th Department of Pediatrics, Faculty of Medicine, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 13, 2011
• Study Start: February 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: February 1, 2013
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

GR (1)