Type 1 Diabetes MellitusNCT01276743
Study of PTPN22 C1858T Polymorphism in Children and Adolescents of Greek Origin With T1DM
An observational study of Type 1 Diabetes Mellitus, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2010to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- For the patients •Subjects who do not meet the criteria above
- For the controls
- •Subjects who do not meet the criteria above
Trial locations and contacts
1 site in 1 country.
Greece1 site
Unit of Pediatric Endocrinology, Diabetes and Metabolism, 4th Department of Pediatrics, Medical School, Aristotle University of Thessaloniki
Thessaloniki, 54603
About this study
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)
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
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T1DM | Children and adolescents with T1DM | |
| Unaffected Population | Population not known to be affected by T1DM |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin
Measured: 3 years
Secondary outcomes (3)
• The association between PTPN22 C1858T polymorphism among patients and gender
Measured: 3 years
• The association between PTPN22 C1858T polymorphism among patients and age of onset of type 1 diabetes mellitus (T1DM)
Measured: 3 years
• The association between the PTPN22 C1858T polymorphism among patients and presence of autoantibodies
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startFeb 2010
- Primary completionJul 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Styliani Giza, Aristotle University Of Thessaloniki
- Investigators
- Assimina Galli-Tsinopoulou, MD, PhD, Study chair, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276743
- Sponsor's protocol ID
- 01051979
- Status last verified
- Feb 2014
- First submitted
- 12 Jan 2011
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01276743
- Acronym / sponsor ID
- 01051979
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T1DM | – | –Children and adolescents with T1DM |
| Unaffected Population | – | –Population not known to be affected by T1DM |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (3 listed)
- For the patients •Subjects who do not meet the criteria above
- For the controls
- •Subjects who do not meet the criteria above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin
Time frame: 3 years
3 secondary outcomes
• The association between PTPN22 C1858T polymorphism among patients and gender
Time frame: 3 years
• The association between PTPN22 C1858T polymorphism among patients and age of onset of type 1 diabetes mellitus (T1DM)
Time frame: 3 years
• The association between the PTPN22 C1858T polymorphism among patients and presence of autoantibodies
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assimina Galli-Tsinopoulou, MD, PhD study chair
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Difference of distribution of PTPN22 C1858T alleles between patients and controls of Greek origin (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.