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

NCT05522504 | Active Not Recruiting

• 1 other identifier: SHSY-IEC-4.1/21-246/01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout Flare; Intercritical Gout; Advanced Gout; Asymptomatic Hyperuricemia

Keywords

PBMC monocyte Treg

Outcome Measures

Primary Outcomes (1)

• remission of gout

  Patients fulfilling all the domains of the 2016 preliminary remission criteria for gout were defined as gout remission group

  6 month

Study Arms (5)

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

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.

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.

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ai Peng: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200272, China

Location

Study Officials

• Ai Peng, MD, PhD

  Shanghai 10th People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the department of Nephrology

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: September 15, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)