Clinical trial NCT04953533: Research and Development of a New Technology for Detection of Abnormal Excretion of Intestinal Uric Acid Involved in the Incidence of Gout
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gout
Hyperuricemia
Gut Microbiota
Uric Acid
Genetic Loci
Single Nucleotide Polymorphism
Feces
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 800
Sex: MALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: gout，hyperuricemia and healthy controls in our hospital.

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.

Eligibility 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. 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.

Primary outcomes:
measure: the difference of the specific Single Nucleotide Polymorphisms(SNPs)
timeFrame: 2021.1.6--2021.12.31
measure: intestinal flora
timeFrame: 2021.1.6--2022.12.31
measure: feces uric acid level
timeFrame: 2021.1.6--2.22.12.31
Secondary outcomes:
measure: the incidence of gout in patients with hyperuricemia
timeFrame: 2021.12.31--2023.12.31
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the second affliated hospital of Zhejiang university School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Xiaoyong Liu, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Lei Liu, PHD
role: STUDY_DIRECTOR
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,
name: Peiyu Zhang, MFA
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Mo Chen, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,
name: Jundi Wang, bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,
name: Shunjie Hu, bachelor
role: PRINCIPAL_INVESTIGATOR
References: