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NCT03106246 Clinical Trial

Circulating Extracellular Vesicles Released by Human Islets of Langerhans

Type2 Diabetes Clinical Trial

Official title:
Immune Response to Extracellular Vesicles Released by Human Islets of Langerhans

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03106246
Other study ID # 15-582-MUHC
Secondary ID
Status Recruiting
Phase N/A
First received March 27, 2017
Last updated April 4, 2017
Start date December 2016
Est. completion date July 2019

Study information
Verified date April 2017
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 2019
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada McGill University Health Center Montreal Quebec

Sponsors (2)
Lead Sponsor Collaborator
McGill University Health Center Centre Hospitalier Universitaire de Québec, CHU de Québec

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 2 years
Primary 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 2 years
Secondary 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, 3 years
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