Distribution of Immune Cells and Their Subtypes in Peripheral Blood of Gout

Active, not recruiting

• Conditions: Advanced Gout; Asymptomatic Hyperuricemia; Gout Flare; Intercritical Gout

• Registration Number: NCT05522504
• Lead Sponsor: Ai Peng

Brief Summary

The purpose of this study is to evaluate whether immune cells and their subtypes in peripheral blood affects the asymptomatic hyperuricemia, gout flare, intercritical gout and advanced gout.

Detailed Description

A number of studies have reported that innate immunity cells (such as blood monocytes and neutrophils) play a crucial role in the initiation and amplification of gout flare resulted from MSU deposition in the joint or tissue, leading to release NLRP3 inflammasome-mediated production of bioactive IL-1β. Further investigation demonstrated the role of blood neutrophils might contribute to the resolution of gout flare by forming aggregated neutrophil extracellular traps. Recently, a few in vitro experiments have indicated that adaptive immunity may be involved in mechanisms of gout. However, a global understanding of blood immune responses underlying gout is still unclear. Thus, we want to investigate the relationship between immune cells and their subtypes in peripheral blood and the gout.

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Study Start: 2022-09-15
• Primary Completion: 2023-02-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-05
• Last Update Posted: 2024-05-08
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• gout flare:diagnosis with gout flare at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015
• intercritical gout: remission of gout patients were classified into intercritical gout group without tophi, chronic gouty arthritis, or imaging erosion(All of these gout remission patients underwent dual-energy CT test within one month, and were detected to have MSU crystal deposition in local joints)
• advanced gout: gout remission patients were classified into advanced gout group characterized by tophi, chronic gouty arthritis, or imaging erosion(All of these gout remission patients underwent dual-energy CT test within one month, and were detected to have MSU crystal deposition in local joints)
• asymptomatic hyperuricemia: hyperuricemia in men was defined as SUA ≥ 420 mmol/L without any complications

Exclusion Criteria

• primary osteoarticular diseases
• unwilling participation in the study
• corticosteroids or indomethacin use in the past 3 months;
• septic arthritis or another joint disease (such as rheumatoid arthritis);
• impaired renal function (creatinine clearance <30 mL/min) and other conditions which may increase the level of blood uric acid

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
remission of gout	6 month	Patients fulfilling all the domains of the 2016 preliminary remission criteria for gout were defined as gout remission group

Trial Locations

Locations (1)

Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China