Study of IGRP-specific T Cell in Peripheral Blood of Type 1 Diabetes Mellitus

June 28, 2017 updated by: First Affiliated Hospital of Zhejiang University
10 type 1 diabetes, 10 type 2 diabetes and 10 healthy controls matched with age and sex were enrolled in our study and their periphera blood mononuclear cells (PBMC) were isolated. We implemented ELISPOT(Enzyme-linked Immunospot Assay) to detect the interferon-γ (IFN-γ）which secreted by IGRP-specific T cell. Results were compared between these groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients of diabetes and healthy controls

Description

Inclusion Criteria:

  • the criteria of type 1 and type 2 diabetes

Exclusion Criteria:

  • no diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
type 1 diabetes
Other: No intervention
No intervention
type 2 diabetes
Other: No intervention
No intervention
healthy people
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the rate of positive reactivation against the IGRP epitopes
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 30, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD be shared while request by email

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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