Diabetes MellitusNCT03136939
Study of IGRP-specific T Cell in Peripheral Blood of Type 1 Diabetes Mellitus
An observational study of Diabetes Mellitus, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
10 type 1 diabetes, 10 type 2 diabetes and 10 healthy controls matched with age and sex were enrolled in our study and their periphera blood mononuclear cells (PBMC) were isolated. We implemented ELISPOT(Enzyme-linked Immunospot Assay) to detect the interferon-γ (IFN-γ）which secreted by IGRP-specific T cell. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 May 2017
- 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: patients of diabetes and healthy controls
Who may be able to join
- the criteria of type 1 and type 2 diabetes
Who cannot join
- no diabetes
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
About this study
10 type 1 diabetes, 10 type 2 diabetes and 10 healthy controls matched with age and sex were enrolled in our study and their periphera blood mononuclear cells (PBMC) were isolated. We implemented ELISPOT(Enzyme-linked Immunospot Assay) to detect the interferon-γ (IFN-γ）which secreted by IGRP-specific T cell. Results were compared between these groups.
- Conditions
- Diabetes Mellitus
- Being tested
- No intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetes | Not described Receives: Other: No intervention | |
| type 2 diabetes | Not described Receives: Other: No intervention | |
| healthy people | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of positive reactivation against the IGRP epitopes
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 Jan 2017
- Primary completion30 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136939
- Sponsor's protocol ID
- 2016-420
- Status last verified
- Apr 2017
- First submitted
- 28 Apr 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD be shared while request by email
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of IGRP-specific T Cell in Peripheral Blood of Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03136939
- Acronym / sponsor ID
- 2016-420
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 2 May 2017 (actual)
- 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.
10 type 1 diabetes, 10 type 2 diabetes and 10 healthy controls matched with age and sex were enrolled in our study and their periphera blood mononuclear cells (PBMC) were isolated. We implemented ELISPOT(Enzyme-linked Immunospot Assay) to detect the interferon-γ (IFN-γ）which secreted by IGRP-specific T cell. Results were compared between these groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetes | – | Other: No intervention |
| type 2 diabetes | – | Other: No intervention |
| healthy people | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients of diabetes and healthy controls
Key inclusion criteria (1 listed)
- the criteria of type 1 and type 2 diabetes
Key exclusion criteria (1 listed)
- no diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | healthy people, type 1 diabetes, type 2 diabetes |
Primary outcome
the rate of positive reactivation against the IGRP epitopes
Time frame: 5 months
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 2 Jul 2017.
- Individual participant dataSharing planned: No. IPD be shared while request by email
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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 Diabetes Mellitus, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 1 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 2 Jul 2017. 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 China. 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?
the rate of positive reactivation against the IGRP epitopes (time frame: 5 months). 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 2 Jul 2017.