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

NCT ID: NCT05522504

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2025-02-28

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.

Conditions

Gout Flare; Intercritical Gout; Advanced Gout; Asymptomatic Hyperuricemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NC

healthy volunteer (Normal control)：(1) aged between 18 and 80 years; (2) The serum UA levels were lower than 420 μmol/L for a man and 360 μmol/L for a woman at least one time during the two clinical tests for the samples collected with 1-week interval; (3) without any clinically diagnostic severe diseases including but not limited to a tumor, diabetes, cardiovascular, renal, nervous, digestive and mental disorders

No interventions assigned to this group

AHU

Asymptomatic Hyperuricemia（AHU） were listed as follows: (1) aged between 18 and 80 years; (2) serum levels of UA were both greater than 420 μmol/L for a man and 360 μmol/L for a woman during the two clinical tests for the samples collected with about 1-week interval; (3) without self-reported history of the acute attack of gout; (4) without receiving medical treatment.

No interventions assigned to this group

AGA

Acute Gout Attack (AGA) were listed as follows: (1) age between 18 and 80 years; (2) diagnosis with AG at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015; (3) and not receiving medical treatment 3 weeks prior to the blood collection.

No interventions assigned to this group

IG

The intercritical gout (IG) remission criteria for gout patients were listed as follows: (1) age between 18 and 80 years; (2) diagnosis with AG at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015; (3) remission of clinical manifestations including redness, swelling, heat, and pain at local joint or bursa for at least three months since the last gout flare; (4) normal level (\<8.20 mg/L) of C-reactive protein (CRP) at the time of blood collection; (5) without tophi, imaging erosion, or chronic gouty arthritis

No interventions assigned to this group

AG

The Advanced gout (AG) criteria for gout patients were listed as follows:(1) age between 18 and 80 years; (2) diagnosis with AG at this hospital according to the criteria approved by the ACR Board of Directors and the EULAR Executive Committee in 2015; (3) remission of clinical manifestations including redness, swelling, heat, and pain at local joint or bursa for at least three months since the last gout flare; (4) normal level (\<8.20 mg/L) of C-reactive protein (CRP) at the time of blood collection; (5) with tophi, imaging erosion, or chronic gouty arthritis

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ai Peng

OTHER

Sponsor Role: lead

Responsible Party

Ai Peng

Director of the department of Nephrology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ai Peng, MD, PhD

Role: STUDY_DIRECTOR

Shanghai 10th People's Hospital

Locations

Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHSY-IEC-4.1/21-246/01

Identifier Type: -

Identifier Source: org_study_id