Recruiting

Extracellular Vesicles

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT03106246

Conditions

Type1 Diabetes Mellitus

Type2 Diabetes

Islet Cell Transplantation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT03106246

Start date

Dec, 2016

Status verified date

Apr, 2017

Completion date

Jul, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Determine the levels of circulating EVs [ Time Frame: 2 years ]
  • Determine whether these EVs contain islet-specific antigens [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

McGill University Health Center

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Sarita Negi

514-934-1934Sarita.negi@muhc.mcgill.ca

Principal Investigator:

Steven Paraskevas, MD PhD

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Apr 10, 2017

Last verified

Apr, 2017

Keywords

  • Extracellular vesicles
  • Autoimmunity
  • Beta-cell injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2017-04-10.