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

NCT04953533 | Unknown

• 1 other identifier: 2020C03044
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• the incidence of gout in patients with hyperuricemia

  2021.12.31--2023.12.31

Study Arms (3)

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

Interventions

no intervention OTHER

healthy controls; patients with gout; patients with hyperuricemia

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

gout，hyperuricemia and healthy controls in our hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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；
• hyperuricemia:
• age:year of 25\~60;
• A medical record in our hospital showed that the person is healthy, without key disease;
• healthy controls:

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the second affliated hospital of Zhejiang university School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

for specific SNP and intestinal microflora

MeSH Terms

Conditions

Gout; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoyong Liu, PHD

  Second Affiliated Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

• Lei Liu, PHD

  Second Affiliated Hospital of Zhejiang University School of Medicine

  STUDY DIRECTOR

• 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,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaxiang Wu, PHD

CONTACT

13757118395; wuhx8855@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: July 8, 2021
• Study Start: July 6, 2021
• Primary Completion: January 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)