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| Name | Class |
|---|---|
| CHU de Quebec-Universite Laval | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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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
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Patients with confirmed Type I and Type II diabetes, patients undergoing islet transplantation and healthy volunteers.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Center | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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Peripheral blood samples. Cellular component will be retained for studies using subject specific peripheral blood mononuclear cells. EV will be purified from plasma and also retained separately.