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

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

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

Official Title
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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

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

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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gout Inclusion Criteria: age:year of 25 60; 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; The patient are willing to take part in our study. Exclusion Criteria: abronia, surgery, postoperative, dehydration within 2 weeks, acute or chronic infectious diseases, severe trauma, malnutrition, diabetes, malignant tumors; diagnosed as cardiovascular and cerebrovascular diseases within 3 months; heart failure (New York Heart Academy，grade IV); hepatic insufficiency ( Alanine transaminase or Aspartate aminotransferase ≥3×upper limit)； chronic kidney disease or abnormal renal function( serum creatinine ≥1.5×upper limit)； excessive drinking； The investigators considered the patients unsuitable for inclusion in this study. hyperuricemia: 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 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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference of the specific Single Nucleotide Polymorphisms(SNPs) | 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 | 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 | 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 | 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 |