Circulating Extracellular Vesicles Released by Human Islets of Langerhans

McGill University

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT03106246

15-582-MUHC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 5 patient groups

New onset T1DM

Description:

Newly diagnosed Type I diabetic patients who are hyperglycemic but still C-peptide positive

T1DM

Description:

Patients with established type I diabetes. they are hyperglycemic but C-peptide negative

T2DM

Description:

Patients with established type II diabetes.

Islet Transplant

Description:

Patients who received an islet transplantation for type I diabetes

Healthy Volunteers

Description:

Normoglycemic healthy volunteers