Type 1 DiabetesPANDANCT00649246
Prospective Assessment in Newborns for Diabetes Autoimmunity
An observational study of Type 1 Diabetes and Autoimmunity, run by Augusta University at 3 sites in United States.
Trial summary
This is an observational study designed to help researchers understand the genetics and pathogenesis of type 1 diabetes, and to identify biomarkers for disease and disease complication prediction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Autoimmunity
- How many people
- 25,055 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 1997to Aug 2010
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: newborns, young children, adults with or without type 1 diabetes
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of South Carolina
Columbia, South Carolina, 29208
University of Florida
Gainesville, Florida, 32608
About this study
Official title: 1. Prospective Studies in Infants of the Immunopathogenesis of Type 1 Diabetes 2. Consortium for Identification of Environmental Triggers of Type 1 Diabetes: MCG/UF Clinical Center 3. Identification of Serum Protein Markers for Type 1 Diabetes Using Mass-Spectrometry Techniques 4. Validation of Microarray-Based Biomarkers for Type 1 Diabetes 5. Development of Microarray-Based Biomarkers for Type 1 Diabetes 6. Proteomic Changes/Progression of Human Type 1 Diabetes 7. Identification and Validation of Serum Biomarkers for T1D
This is an observational study designed to help researchers understand the genetics and pathogenesis of type 1 diabetes, and to identify biomarkers for disease and disease complication prediction.
Read the detailed description
This study is designed to identify people who are at risk for developing type 1 diabetes, based on their genetics, family history and autoimmunity status, and to understand the role genetics plays in the development of the complications associated with type 1 diabetes in patients already affected by type 1 diabetes.
- Conditions
- Type 1 Diabetes, Autoimmunity
- Keywords
- genetics, type 1 diabetes, biomarkers, autoimmunity
- Medical subject headings
- Diabetes Mellitus, Type 1, Autoimmune Diseases
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 |
|---|---|---|
| 1 | controls: healthy individuals with no family history of type 1 diabetes | |
| 2 | high-risk: Subjects with islet autoantibodies or high-risk diabetes genes | |
| 3 | type 1 diabetes: subjects with type 1 diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
autoantibodies against the pancreas and type 1 diabetes
Measured: 50 years
Secondary outcomes (1)
Risk factors for type 1 diabetes
Measured: 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJul 1997
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,055 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Florida, Emory University, Medical University of South Carolina, University of South Carolina
- Responsible party
- Principal investigator, Jin-Xiong She, Augusta University
- Investigators
- Jin Xiong She, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649246
- Sponsor's protocol ID
- DK63865 - PANDA
- Other IDs
- U01DK063865
- Acronym
- PANDA
- Status last verified
- Mar 2018
- First submitted
- 28 Mar 2008
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1. Prospective Studies in Infants of the Immunopathogenesis of Type 1 Diabetes 2. Consortium for Identification of Environmental Triggers of Type 1 Diabetes: MCG/UF Clinical Center 3. Identification of Serum Protein Markers for Type 1 Diabetes Using Mass-Spectrometry Techniques 4. Validation of Microarray-Based Biomarkers for Type 1 Diabetes 5. Development of Microarray-Based Biomarkers for Type 1 Diabetes 6. Proteomic Changes/Progression of Human Type 1 Diabetes 7. Identification and Validation of Serum Biomarkers for T1D
- ClinicalTrials.gov ID
- NCT00649246
- Acronym / sponsor ID
- PANDA / DK63865 - PANDA
- Conditions
- Type 1 Diabetes, Autoimmunity
- Keywords
- genetics, type 1 diabetes, biomarkers, autoimmunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,055 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Florida, Emory University, Medical University of South Carolina, University of South Carolina
- Study start
- Jul 1997
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 1 Apr 2008 (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.
This is an observational study designed to help researchers understand the genetics and pathogenesis of type 1 diabetes, and to identify biomarkers for disease and disease complication prediction.
Detailed description
This study is designed to identify people who are at risk for developing type 1 diabetes, based on their genetics, family history and autoimmunity status, and to understand the role genetics plays in the development of the complications associated with type 1 diabetes in patients already affected by type 1 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –controls: healthy individuals with no family history of type 1 diabetes |
| 2 | – | –high-risk: Subjects with islet autoantibodies or high-risk diabetes genes |
| 3 | – | –type 1 diabetes: subjects with type 1 diabetes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- newborns, young children, adults with or without type 1 diabetes
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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
autoantibodies against the pancreas and type 1 diabetes
Time frame: 50 years
1 secondary outcome
Risk factors for type 1 diabetes
Time frame: 50 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 27 Mar 2018.
- PANDA web siteLink provided by the sponsor.
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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.
Jin Xiong She, PhD principal investigator
Augusta University
3 sites 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 and Autoimmunity, run by Augusta University at 3 sites in United States.
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 0 inclusion and 1 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 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
autoantibodies against the pancreas and type 1 diabetes (time frame: 50 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 27 Mar 2018.