Circulating Extracellular Vesicles Released by Human Islets of Langerhans

April 4, 2017 updated by: Dr. Steven Paraskevas, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Center
        • Contact:
        • Principal Investigator:
          • Steven Paraskevas, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with confirmed Type I and Type II diabetes, patients undergoing islet transplantation and healthy volunteers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mutivariate analysis will be performed with patient parameters and EV parameters
Time Frame: 3 years
Correlate levels of EVs containing islet specific markers to patient parameters like age, duration of established diabetes, levels of autoantibodies,
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

CHU de Quebec-Universite Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

March 27, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (ACTUAL)

April 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-582-MUHC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type2 Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe