The Relationship Between NK Cell and Graves' Disease

Graves Disease Clinical Trial

Official title:

Mechanism of NK Cell Disfunction in Graves' Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04135573
• Other study ID #: 2018109
• Status: Active, not recruiting
• Start date: October 15, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2021
• Source: Shandong Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Graves Disease

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and function of NK cells changes of hyperthyroidism	Flow cytometry used to measure the related changes of NK cells in hyperthyroidism	measured after 2 years of follow-up
Secondary	Changes in serum levels	Detection of related cytokines by ELISA	measured after 2 years of follow-up