Circulating Extracellular Vesicles Released by Human Islets of Langerhans

NCT03106246 | Unknown

• 1 other identifier: 15-582-MUHC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes Mellitus; Type2 Diabetes; Islet Cell Transplantation

Keywords

Extracellular vesicles; Autoimmunity; Beta-cell injury

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Mutivariate analysis will be performed with patient parameters and EV parameters

  3 years

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed Type I and Type II diabetes, patients undergoing islet transplantation and healthy volunteers.

You may qualify if:

• Age 18-70 Diagnosis of type 1 diabetes or type 2 diabetes or islet transplant recipient

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• CHU de Quebec-Universite Laval: collaborator

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 10, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2019
• Last Updated: April 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)