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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04953533
Enrollment
800
Registered
2021-07-08
Start date
2021-07-06
Completion date
2023-12-31
Last updated
2021-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feces, Genetic Loci, Gout, Gut Microbiota, Hyperuricemia, Single Nucleotide Polymorphism, Uric Acid

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.

Interventions

OTHERno intervention

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
25 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
the difference of the specific Single Nucleotide Polymorphisms(SNPs)2021.1.6--2021.12.31We 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 flora2021.1.6--2022.12.31Feces 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 level2021.1.6--2.22.12.31Feces 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

MeasureTime frameDescription
the incidence of gout in patients with hyperuricemia2021.12.31--2023.12.31follow-up the patients with hyperuricemia for at least one year, calculate the incidence of hyperuricemia patients develop to gout.

Countries

China

Contacts

Primary ContactHuaxiang Wu, PHD
wuhx8855@sina.com13757118395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026