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

• Conditions: Gout; Gut Microbiota; Genetic Loci; Uric Acid; Feces; Hyperuricemia; Single Nucleotide Polymorphism

• Registration Number: NCT04953533
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

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 Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-03-16
• Study Start: 2021-07-06
• Study First Submitted QC: 2021-07-06
• Last Update Submitted: 2021-07-06
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08
• Primary Completion: 2023-01-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the difference of the specific Single Nucleotide Polymorphisms(SNPs)	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.
intestinal flora	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.
feces uric acid level	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.

Secondary Outcome Measures

Name	Time	Method
the incidence of gout in patients with hyperuricemia	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.

Trial Locations

Locations (1)

the second affliated hospital of Zhejiang university School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China