Circulating Extracellular Vesicles Released by Human Islets of Langerhans

• Conditions: Type1 Diabetes Mellitus; Islet Cell Transplantation; Type2 Diabetes

• Registration Number: NCT03106246
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

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 Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-03-27
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Study First Posted: 2017-04-10
• Last Update Posted: 2017-04-10
• Primary Completion: 2018-12
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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,

Trial Locations

Locations (1)

McGill University Health Center; 🇨🇦 Montreal, Quebec, Canada