The Genetic Variation of Type 1 DiabetesPATTNCT01955746
PST Linkage Based Analysis in the Family of More Than Two Members With Type 1 Diabetes in Taiwan
An observational study of The Genetic Variation of Type 1 Diabetes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to explore the susceptible genes for Type 1 diabetes in Taiwan through the new genetic study methods. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- The Genetic Variation of Type 1 Diabetes
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2013to Jun 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The family of more than one member with T1D
Who may be able to join
- Type 1 diabetes on the criteria of the American Diabetes Association with a very low C-peptide level (<0.35 ng/mL) with or without the experience of diabetic ketoacidosis.
- The subjects whose four grandparents are of Chinese Han origin
Who cannot join
- Patients with ages of onset more than 35 years are excluded.
- The families having any member with known possible type 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parent-sibling Tracing (PST) Linkage Based Analysis in the Family of More Than Two Members With Type 1 Diabetes in Taiwan for Novel HLA and Non-HLA Candidate Risk Alleles Detection
The purpose of this study is to explore the susceptible genes for Type 1 diabetes in Taiwan through the new genetic study methods.
Read the detailed description
As an unclear autoimmune disorder, the pathogenesis of type 1 diabetes (T1D) remains elusive. Among all the methods for studying diseases pathophysiology, genetic approach has valuable capability as being both hypothesis-testing and hypothesis-generating. Although geo-epidemiological studies show relatively higher prevalence of T1D in Caucasians than in Asians, whether genetic factors identified in T1D of Caucasians are essential for T1D in Asians is not yet clarified. Although the human leukocyte antigen (HLA) genotype variants have been reported to be associated with T1D, the odds ratio (ORs) is relatively low in Taiwan as comparing with western countries, some families are indeed more than one child with T1D. However, the genetic linkage study in T1D is still limited in Taiwan that hampered the drug development or research in T1D. Therefore, we intend to explore the susceptible genes for T1D of Taiwan in this study, which will provide further researcher directions for this disease.
- Conditions
- The Genetic Variation of Type 1 Diabetes
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 |
|---|---|---|
| Type 1 DM | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 1 diabetes gene
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Genetic Variation of Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955746
- Sponsor's protocol ID
- CMRPG3C1151
- Acronym
- PATT
- Status last verified
- Sep 2013
- First submitted
- 30 Sep 2013
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-sibling Tracing (PST) Linkage Based Analysis in the Family of More Than Two Members With Type 1 Diabetes in Taiwan for Novel HLA and Non-HLA Candidate Risk Alleles Detection
- ClinicalTrials.gov ID
- NCT01955746
- Acronym / sponsor ID
- PATT / CMRPG3C1151
- Conditions
- The Genetic Variation of Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Oct 2013 (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 purpose of this study is to explore the susceptible genes for Type 1 diabetes in Taiwan through the new genetic study methods.
Detailed description
As an unclear autoimmune disorder, the pathogenesis of type 1 diabetes (T1D) remains elusive. Among all the methods for studying diseases pathophysiology, genetic approach has valuable capability as being both hypothesis-testing and hypothesis-generating. Although geo-epidemiological studies show relatively higher prevalence of T1D in Caucasians than in Asians, whether genetic factors identified in T1D of Caucasians are essential for T1D in Asians is not yet clarified. Although the human leukocyte antigen (HLA) genotype variants have been reported to be associated with T1D, the odds ratio (ORs) is relatively low in Taiwan as comparing with western countries, some families are indeed more than one child with T1D. However, the genetic linkage study in T1D is still limited in Taiwan that hampered the drug development or research in T1D. Therefore, we intend to explore the susceptible genes for T1D of Taiwan in this study, which will provide further researcher directions for this disease.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 DM | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The family of more than one member with T1D
Key inclusion criteria (2 listed)
- Type 1 diabetes on the criteria of the American Diabetes Association with a very low C-peptide level (<0.35 ng/mL) with or without the experience of diabetic ketoacidosis.
- The subjects whose four grandparents are of Chinese Han origin
Key exclusion criteria (2 listed)
- Patients with ages of onset more than 35 years are excluded.
- The families having any member with known possible type 2 diabetes
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
Type 1 diabetes gene
Time frame: 1 year
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 11 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 The Genetic Variation of Type 1 Diabetes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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 11 Jun 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 Taiwan. 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?
Type 1 diabetes gene (time frame: 1 year). 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 11 Jun 2014.