The Relationship Between NK Cell and Graves' Disease

April 12, 2021 updated by: Hai-qing Zhang, Shandong Provincial Hospital

Mechanism of NK Cell Disfunction in Graves' Disease

Graves' disease (GD) is one of organ specific autoimmune diseases, the pathogenesis is not elucidated.Natural Killer (Natural Killer, NK) cells is a kind of important immune regulator, several abnormalities of NK cell function and number in GD patients have been described in the investigators' previous study. It is remain unclear whether the NK cell disfunction is a consequence of GD.Based on the investigators' previous study, the investigators plan to monitor NK cell function in participants in the whole course of disease, analyze the association with relevant factors, such as thyroid function, immune state or treatment,to find out influences of thyroid hormones and thyroid receptor antibody affecting the function of NK cell. The investigators will reveal whether the disfunction of NK cell secondary to GD abnormal thyroid function and/or immune disorders, and realize the mechanics.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

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
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults aged of 18 to 75 years old

Description

Inclusion Criteria:

  • New GD patients without any treatment
  • Aged of 18 to 75 years old

Exclusion Criteria:

  • Pregnant or lactating woman;
  • Known autoimmune disease;
  • Receiving psychotropic or hormonal drugs;
  • Taking drugs that affect the body's immune function;
  • Obviously poor compliance.

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
New untreated GD patients
Before treatment and application of anti-thyroid drugs (methimazole) or radioactive iodine treatment
Healthy control
No thyroid related diseases and other immune diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number and function of NK cells changes of hyperthyroidism
Time Frame: measured after 2 years of follow-up
Flow cytometry used to measure the related changes of NK cells in hyperthyroidism
measured after 2 years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in serum levels
Time Frame: measured after 2 years of follow-up
Detection of related cytokines by ELISA
measured after 2 years of follow-up

Collaborators and Investigators

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

Sponsor

Shandong Provincial Hospital

Investigators

  • Study Chair: Haiqing Zhang, Shandong Provincial Hospital

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)

October 15, 2018

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

October 20, 2019

First Posted (Actual)

October 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Graves Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe