Research and Development of a New Technology for Detection of Abnormal Excretion of Intestinal Uric Acid Involved in the Incidence of Gout

July 6, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Research on New Technologies for Diagnosis and Treatment of Skin Diseases and Venereal Diseases and Rheumatoid Diseases-- Research and Development of a New Technology for Detection of Abnormal Excretion of Intestinal Uric Acid Involved in the Incidence of Gout

To evaluate differences in specific SNPs and intestinal microflora between patients with gout and hyperuricemia and healthy controls.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. To evaluate differences in specific SNPs and intestinal microflora between patients with gout and hyperuricemia and healthy controls.
  2. to measure the level of uric acid in feces.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affliated Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

gout，hyperuricemia and healthy controls in our hospital.

Description

gout

Inclusion Criteria:

  1. age:year of 25~60;
  2. Be consistent with the 2015 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) gout diagnostic criteria ,and serum uric acid >420 μmol/L;
  3. The patient are willing to take part in our study.

Exclusion Criteria:

  1. abronia, surgery, postoperative, dehydration within 2 weeks, acute or chronic infectious diseases, severe trauma, malnutrition, diabetes, malignant tumors;
  2. diagnosed as cardiovascular and cerebrovascular diseases within 3 months;
  3. heart failure (New York Heart Academy，grade IV);
  4. hepatic insufficiency ( Alanine transaminase or Aspartate aminotransferase ≥3×upper limit)；
  5. chronic kidney disease or abnormal renal function( serum creatinine ≥1.5×upper limit)；
  6. excessive drinking；
  7. The investigators considered the patients unsuitable for inclusion in this study.

hyperuricemia:

Inclusion Criteria:

  1. age:year of 25~60;
  2. A medical record in our hospital showed that the person is healthy, without key disease;
  3. serum uric acid >420μmol/L without gout flares. Exclusion Criteria:Same as the group of gout.

healthy controls:

Inclusion Criteria:

age:year of 25~60; A medical record in our hospital showed that the person is healthy, without key disease; serum uric acid ≤420μmol/L. Exclusion Criteria:Same as the group of gout.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with gout
  1. age:year of 25~60;
  2. consistent with the 2015 ACR gout diagnostic criteria ,and serum uric acid >420umol/L;
  3. The patient are willing to take part in our study.
Other: no intervention
patients with hyperuricemia
  1. age:year of 25~60;
  2. A medical record in our hospital showed that the person is healthy, without key disease;
  3. serum uric acid >420umol/L without gout flares.
Other: no intervention
healthy controls
  1. age:year of 25~60;
  2. A medical record in our hospital showed that the person is healthy, without key disease;
  3. serum uric acid ≤420umol/L.
Other: no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the difference of the specific Single Nucleotide Polymorphisms(SNPs)
Time Frame: 2021.1.6--2021.12.31
We will test the specific SNPs that we have selected before, such as rs670, rs671, rs1014290 and so on. The SNPs will be tested by Taqman SNP assay and verified by sequencing.
2021.1.6--2021.12.31
intestinal flora
Time Frame: 2021.1.6--2022.12.31
Feces will be collected in gout, hyperuricemia patients and healthy subjects. ofIntestinal flora will be tested and analysed. The detailed measurement is as follows: Firstly, the DNA of feces will be extracted according to the protocol of Fecal DNA Extraction Kit. Then, the concentration and purity of fecal DNA will be tested by spectrophotometer. Sequencing of the V3-V4 region of the 16S ribosomal RNA gene, building a library and then sequencing the qualified libraries by Illumina Platform(MiSeq). Using the QIIME、UCLUST、SILVA and Kyoto Encyclopedia of Genes and Genomes(KEGG) database to comparison and screen the intestinal bacterial with statistical significance. Operational taxonomic unit (OTU), α-diversity, β-diversity indices and so on of the fecal microbiota will be analyzed in patients with gout and hyperuricemia and normal control.
2021.1.6--2022.12.31
feces uric acid level
Time Frame: 2021.1.6--2.22.12.31
Feces uric acid level will be tested by uric acid assay kit and we will analyze the differences of feces uric acid level in gout, hyperuricemia patients and healthy subjects.
2021.1.6--2.22.12.31

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of gout in patients with hyperuricemia
Time Frame: 2021.12.31--2023.12.31
follow-up the patients with hyperuricemia for at least one year, calculate the incidence of hyperuricemia patients develop to gout.
2021.12.31--2023.12.31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Xiaoyong Liu, PHD, Second Affiliated Hospital of Zhejiang University School of Medicine
  • Study Director: Lei Liu, PHD, Second Affiliated Hospital of Zhejiang University School of Medicine
  • Principal Investigator: Peiyu Zhang, MFA, Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,
  • Principal Investigator: Mo Chen, PHD, Second Affiliated Hospital of Zhejiang University School of Medicine
  • Principal Investigator: Jundi Wang, bachelor, Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,
  • Principal Investigator: Shunjie Hu, bachelor, Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 6, 2021

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020C03044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

For the time being, we decided not to share individual participant data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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