Study of IGRP-specific T Cell in Peripheral Blood of Type... | NCT03136939

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

NCT03136939

Sponsor

First Affiliated Hospital of Zhejiang University

Status

Completed

Last Update Posted

Jul 2, 2017Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

May 30, 2017Actual

Completion Date

May 31, 2017Actual

First Submitted Date

Apr 28, 2017

First Submission Date that Met QC Criteria

Apr 28, 2017

First Posted Date

May 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2017

Last Update Posted Date

Jul 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
type 1 diabetes			Other: No intervention
type 2 diabetes			Other: No intervention
healthy people			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	healthy people type 1 diabetes type 2 diabetes

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the criteria of type 1 and type 2 diabetes

Exclusion Criteria:

no diabetes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients of diabetes and healthy controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine		Hangzhou	Zhejiang	310003	China

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD be shared while request by email

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided