Clinical trial NCT05522504: Distribution of Immune Cells and Their Subtypes in Peripheral Blood of Gout
Official title: Distribution of Immune Cells and Their Subtypes in Peripheral Blood of Gout
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gout Flare
Intercritical Gout
Advanced Gout
Asymptomatic Hyperuricemia
Keywords: PBMC monocyte Treg
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asymptomatic hyperuricemia Gout flare patients Gout remission patients were classified into intercritical gout group without tophi, chronic gouty arthritis, or imaging erosion, while others 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) Healthy Volunteers

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.

Eligibility criteria: 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

Primary outcomes:
measure: remission of gout
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Ai Peng, MD, PhD
role: STUDY_DIRECTOR
References: