Type1 Diabetes MellitusNCT03106246
Circulating Extracellular Vesicles Released by Human Islets of Langerhans
An observational study of Type1 Diabetes Mellitus and Type2 Diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Beta-cells release extracellular vesicles (EV) and exosomes under normal and pathophysiologic conditions. These EV contain beta-cell specific autoantigens which may trigger the immune response at the initiation of type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type1 Diabetes Mellitus, Type2 Diabetes, Islet Cell Transplantation
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2016to Jul 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with confirmed Type I and Type II diabetes, patients undergoing islet transplantation and healthy volunteers.
Who may be able to join
- Age 18-70 Diagnosis of type 1 diabetes or type 2 diabetes or islet transplant recipient
Who cannot join
- Unknown diagnosis of diabetes Active infection Immunocompromised Organ transplant recipients not including candidates for islet transplant HIV+ Hepatitis C+ Hepatitis B surface antigen+ Known concurrent malignancy Known pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Center
Montreal, Quebec, H4A 3J1
Sarita Negi, 514-934-1934, Sarita.negi@muhc.mcgill.ca
Steven Paraskevas, MD PhD
About this study
Official title: Immune Response to Extracellular Vesicles Released by Human Islets of Langerhans
Beta-cells release extracellular vesicles (EV) and exosomes under normal and pathophysiologic conditions. These EV contain beta-cell specific autoantigens which may trigger the immune response at the initiation of type 1 diabetes. In this study, beta-cell derived EV will be detected and characterized in human blood samples.
Read the detailed description
Adult subjects will be recruited with: new onset type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) as well as islet transplant candidates. Blood samples will be collected at defined intervals to determine beta-cell specific EV and determine the utility of this biomarker as a measure of beta-cell stress or injury.
- Keywords
- Extracellular vesicles, Autoimmunity, Beta-cell injury
- Medical subject headings
- 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 |
|---|---|---|
| New onset T1DM | Newly diagnosed Type I diabetic patients who are hyperglycemic but still C-peptide positive | |
| T1DM | Patients with established type I diabetes. they are hyperglycemic but C-peptide negative | |
| T2DM | Patients with established type II diabetes. | |
| Islet Transplant | Patients who received an islet transplantation for type I diabetes | |
| Healthy Volunteers | Normoglycemic healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the levels of circulating EVs
Based on well-known EV markers, subject plasma samples will be characterized to determine whether these EVs are detectable using small particle flow cytometry.
Measured: 2 years
Determine whether these EVs contain islet-specific antigens
EVs will be further characterized using small particle flow cytometry for known islet-specific antigens such as GAD65 and ZnT8
Measured: 2 years
Secondary outcomes (1)
Mutivariate analysis will be performed with patient parameters and EV parameters
Correlate levels of EVs containing islet specific markers to patient parameters like age, duration of established diabetes, levels 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 posted10 Apr 2017
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval
- Responsible party
- Principal investigator, Dr. Steven Paraskevas, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106246
- Sponsor's protocol ID
- 15-582-MUHC
- Status last verified
- Apr 2017
- First submitted
- 27 Mar 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Extracellular Vesicles Released by Human Islets of Langerhans
- ClinicalTrials.gov ID
- NCT03106246
- Acronym / sponsor ID
- 15-582-MUHC
- Keywords
- Extracellular vesicles, Autoimmunity, Beta-cell injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 10 Apr 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.
Beta-cells release extracellular vesicles (EV) and exosomes under normal and pathophysiologic conditions. These EV contain beta-cell specific autoantigens which may trigger the immune response at the initiation of type 1 diabetes. In this study, beta-cell derived EV will be detected and characterized in human blood samples.
Detailed description
Adult subjects will be recruited with: new onset type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) as well as islet transplant candidates. Blood samples will be collected at defined intervals to determine beta-cell specific EV and determine the utility of this biomarker as a measure of beta-cell stress or injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| New onset T1DM | – | –Newly diagnosed Type I diabetic patients who are hyperglycemic but still C-peptide positive |
| T1DM | – | –Patients with established type I diabetes. they are hyperglycemic but C-peptide negative |
| T2DM | – | –Patients with established type II diabetes. |
| Islet Transplant | – | –Patients who received an islet transplantation for type I diabetes |
| Healthy Volunteers | – | –Normoglycemic healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed Type I and Type II diabetes, patients undergoing islet transplantation and healthy volunteers.
Key inclusion criteria (1 listed)
- Age 18-70 Diagnosis of type 1 diabetes or type 2 diabetes or islet transplant recipient
Key exclusion criteria (1 listed)
- Unknown diagnosis of diabetes Active infection Immunocompromised Organ transplant recipients not including candidates for islet transplant HIV+ Hepatitis C+ Hepatitis B surface antigen+ Known concurrent malignancy Known pregnancy
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
Determine the levels of circulating EVs
Time frame: 2 years
Based on well-known EV markers, subject plasma samples will be characterized to determine whether these EVs are detectable using small particle flow cytometry.
Determine whether these EVs contain islet-specific antigens
Time frame: 2 years
EVs will be further characterized using small particle flow cytometry for known islet-specific antigens such as GAD65 and ZnT8
1 secondary outcome
Mutivariate analysis will be performed with patient parameters and EV parameters
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Individual participant dataSharing planned: No
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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.
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 Type1 Diabetes Mellitus and Type2 Diabetes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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: status not confirmed, as of the sponsor's last update on 10 Apr 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the levels of circulating EVs (time frame: 2 years). The study lists 2 primary outcomes in all. 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 10 Apr 2017.