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The Relationship Between NK Cell and Graves' Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04135573
Recruitment Status : Active, not recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Information provided by (Responsible Party):
Hai-qing Zhang, Shandong Provincial Hospital

Brief Summary:
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.

Condition or disease
Graves Disease

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Mechanism of NK Cell Disfunction in Graves' Disease
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Changes in serum levels [ Time Frame: measured after 2 years of follow-up ]
    Detection of related cytokines by ELISA

Biospecimen Retention:   Samples With DNA
serum,whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults aged of 18 to 75 years old

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04135573

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China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Sponsors and Collaborators
Shandong Provincial Hospital
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Study Chair: Haiqing Zhang Shandong Provincial Hospital
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Responsible Party: Hai-qing Zhang, professor, Shandong Provincial Hospital Identifier: NCT04135573    
Other Study ID Numbers: 2018109
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hai-qing Zhang, Shandong Provincial Hospital:
Atuoimmune thyroid disease
Graves' disease
Natural killer cell
Additional relevant MeSH terms:
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Graves Disease
Orbital Diseases
Eye Diseases
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases