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Circulating Extracellular Vesicles Released by Human Islets of Langerhans

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
Overall Status
Unknown status
CT.gov ID
NCT03106246
Collaborator
CHU de Quebec-Universite Laval (Other)
100
Enrollment
1
Location
30.9
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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. In this study, beta-cell derived EV will be detected and characterized in human blood samples.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Immune Response to Extracellular Vesicles Released by Human Islets of Langerhans
    Study Start Date :
    Dec 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2018
    Anticipated Study Completion Date :
    Jul 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Determine the levels of circulating EVs [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.

    2. Determine whether these EVs contain islet-specific antigens [2 years]

      EVs will be further characterized using small particle flow cytometry for known islet-specific antigens such as GAD65 and ZnT8

    Secondary Outcome Measures

    1. Mutivariate analysis will be performed with patient parameters and EV parameters [3 years]

      Correlate levels of EVs containing islet specific markers to patient parameters like age, duration of established diabetes, levels of autoantibodies,

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Age 18-70 Diagnosis of type 1 diabetes or type 2 diabetes or islet transplant recipient

    Exclusion Criteria:

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 McGill University Health Center Montreal Quebec Canada H4A 3J1

    Sponsors and Collaborators

    • McGill University Health Centre/Research Institute of the McGill University Health Centre
    • CHU de Quebec-Universite Laval

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Steven Paraskevas, Associate Professor of Surgery, McGill University Health Centre/Research Institute of the McGill University Health Centre
    ClinicalTrials.gov Identifier:
    NCT03106246
    Other Study ID Numbers:
    • 15-582-MUHC
    First Posted:
    Apr 10, 2017
    Last Update Posted:
    Apr 10, 2017
    Last Verified:
    Apr 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Dr. Steven Paraskevas, Associate Professor of Surgery, McGill University Health Centre/Research Institute of the McGill University Health Centre
    Extracellular vesicles
    Autoimmunity
    Beta-cell injury
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Apr 10, 2017