Circulating Extracellular Vesicles Released by Human Islets of Langerhans

Immune Response to Extracellular Vesicles Released by Human Islets of Langerhans

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03106246

Enrollment

100

Registered

2017-04-10

Start date

2016-12-31

Completion date

2019-07-31

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Islet Cell Transplantation, Type1 Diabetes Mellitus, Type2 Diabetes

Keywords

Extracellular vesicles, Autoimmunity, Beta-cell injury

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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,

Countries

Canada

Outcome results