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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04953533
• Other study ID #: 2020C03044
• Status: Recruiting
• Start date: July 6, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Huaxiang Wu, PHD
• Phone: 13757118395
• Email: wuhx8855[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout
• Gut Microbiota
• Hyperuricemia
• Single Nucleotide Polymorphism
• Uric Acid

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
China	the second affliated hospital of Zhejiang university School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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), a-diversity, ß-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
Primary	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	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