Study of PTPN22 C1858T Polymorphism in Children and Adole... | NCT01276743

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

NCT01276743

Sponsor

Aristotle University Of Thessaloniki

Status

Completed

Last Update Posted

Feb 28, 2014Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Type 1 Diabetes Mellitus

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Feb 2013Actual

First Submitted Date

Jan 12, 2011

First Submission Date that Met QC Criteria

Jan 12, 2011

First Posted Date

Jan 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2014

Last Update Posted Date

Feb 28, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Styliani Giza, MD, MSc, PhD, 4th Department of Pediatrics, Faculty of Medicine, Aristotle University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece, Aristotle University Of ThessalonikiPrincipal Investigator

Lead Sponsor

Aristotle University Of ThessalonikiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Actual

Label	Type	Description	Intervention Names
T1DM		Children and adolescents with T1DM
Unaffected Population		Population not known to be affected by T1DM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
• Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin		3 years

Secondary Outcomes

Measure	Description	Time Frame
• 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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Assimina Galli-Tsinopoulou, MD, PhD	Aristotle University Of Thessaloniki	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unit of Pediatric Endocrinology, Diabetes and Metabolism, 4th Department of Pediatrics, Medical School, Aristotle University of Thessaloniki		Thessaloniki		54603	Greece

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases