GoutNCT04953533
Research and Development of a New Technology for Detection of Abnormal Excretion of Intestinal Uric Acid Involved in the Incidence of Gout
An observational study of Gout and Hyperuricemia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To evaluate differences in specific SNPs and intestinal microflora between patients with gout and hyperuricemia and healthy controls. Read more about this study
- Who is it for?
- Ages 25 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gout, Hyperuricemia, Gut Microbiota
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: gout，hyperuricemia and healthy controls in our hospital.
Who may be able to join
- 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.
- 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:
- 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.
Who cannot join
- 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:
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the second affliated hospital of Zhejiang university School of Medicine
Hangzhou, Zhejiang, 310000
Huaxiang Wu, PHD, 13757118395, wuhx8855@sina.com
About this study
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
To evaluate differences in specific SNPs and intestinal microflora between patients with gout and hyperuricemia and healthy controls.
Read the detailed description
- 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.
- Conditions
- Gout, Hyperuricemia, Gut Microbiota, Uric Acid, Genetic Loci, Single Nucleotide Polymorphism
- Being tested
- no intervention
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2021.1.6--2.22.12.31
Secondary outcomes (1)
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.
Measured: 2021.12.31--2023.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start6 Jul 2021 (estimated)
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoyong Liu, PHD, Principal investigator, Second Affiliated Hospital of Zhejiang University School of MedicineLei Liu, PHD, Study director, Second Affiliated Hospital of Zhejiang University School of MedicinePeiyu Zhang, MFA, Principal investigator, Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,Mo Chen, PHD, Principal investigator, Second Affiliated Hospital of Zhejiang University School of MedicineJundi Wang, bachelor, Principal investigator, Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,Shunjie Hu, bachelor, Principal investigator, Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953533
- Sponsor's protocol ID
- 2020C03044
- Status last verified
- Jan 2021
- First submitted
- 16 Mar 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For the time being, we decided not to share individual participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04953533
- Acronym / sponsor ID
- 2020C03044
- Conditions
- Gout, Hyperuricemia, Gut Microbiota, Uric Acid, Genetic Loci, Single Nucleotide Polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 6 Jul 2021 (estimated)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate differences in specific SNPs and intestinal microflora between patients with gout and hyperuricemia and healthy controls.
Detailed description
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with gout | – | Other: no intervention1. 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. |
| patients with hyperuricemia | – | Other: no intervention1. 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. |
| healthy controls | – | Other: no intervention1. 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- gout，hyperuricemia and healthy controls in our hospital.
Key inclusion criteria (8 listed)
- 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.
- age:year of 25~60;
- A medical record in our hospital showed that the person is healthy, without key disease;
Key exclusion criteria (8 listed)
- 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)；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | healthy controls, patients with gout, patients with hyperuricemia |
Primary outcome
the difference of the specific Single Nucleotide Polymorphisms(SNPs)
Time frame: 2021.1.6--2021.12.31
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.
intestinal flora
Time frame: 2021.1.6--2022.12.31
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.
feces uric acid level
Time frame: 2021.1.6--2.22.12.31
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.
1 secondary outcome
the incidence of gout in patients with hyperuricemia
Time frame: 2021.12.31--2023.12.31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No. For the time being, we decided not to share individual participant data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyong Liu, PHD principal investigator
Second Affiliated Hospital of Zhejiang University School of Medicine
Lei Liu, PHD study director
Second Affiliated Hospital of Zhejiang University School of Medicine
Peiyu Zhang, MFA principal investigator
Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang university,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gout and Hyperuricemia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huaxiang Wu, PHD (13757118395, wuhx8855@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the difference of the specific Single Nucleotide Polymorphisms(SNPs) (time frame: 2021.1.6--2021.12.31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.