HyperuricemiaNCT06984575
Relationship Between Intestinal Flora Changes and Hyperuricemia Under Chronic Psychological Stress
An observational study of Hyperuricemia, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To clarify the mechanism of stress on the incidence of hyperuricemia Read more about this study
- Who is it for?
- Ages 18 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 May 2025
- 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 18 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hyperuricemia patients and healthy controls
Who may be able to join
- Obtain the informed consent of the subjects before conducting any trial-related activities;
- Males aged 18-69;
- The hyperurcemia group must meet the diagnostic criteria of having blood uric acid >420umol/L measured twice on an empty stomach on different days under a normal purine diet;
Who cannot join
- 1)Use of any uric acid-lowering drugs, anti-gout drugs, steroids, proton pump inhibitors, or non-steroidal anti-inflammatory drugs within one month before enrollment; 2)Use of any antibiotics, probiotics, or other drugs including traditional Chinese medicine within one month before enrollment; 3)Abnormal liver function, ALT and AST are more than 2.5 times the upper limit of normal; 4)Other diseases that affect glucose and lipid metabolism: hyperthyroidism, hypothyroidism, hypercortisolism, etc.
- 5)Chronic kidney disease or severe renal impairment, according to eGFR grading <45mL/min/1.73m2; 6)Secondary hyperuricemia 7)Any gastrointestinal diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's hospital
Shanghai, Shanghai Municipality, 200070
About this study
To clarify the mechanism of stress on the incidence of hyperuricemia
Read the detailed description
To clarify the differences in intestinal microorganisms and metabolism between healthy people and hyperuricemia patients and across different level of stress
- Conditions
- Hyperuricemia
- Being tested
- No interventions
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| LSC | healthy people with low level of stress Receives: Other: No interventions | |
| HSC | healthy people with high level of stress Receives: Other: No interventions | |
| LSH | hyperuricemia patients with low level of stress Receives: Other: No interventions | |
| HSH | hyperuricemia patients with high level of stress Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenotype differences in the gut microbiome by metagenomic sequencing.
including microbial composition analysis(Taxonomic Annotation Tools: MetaPhlAn4; Functional Gene Analysis Tools:eggNOG-mapper (functional classification) and diversity metrics(α-diversity (Shannon index) and β-diversity (Bray-Curtis distance, UniFrac distance)
Measured: Samples to be collected once per participant within 7 days of enrollment
sequencing results of the fecal metabolome in the population
Measured: Samples to be collected once per participant within 7 days of enrollment
Secondary outcomes (1)
Serum uric acid
Uric acid in umol/L.
Measured: Samples to be collected once per participant within 7 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Sep 2023
- Primary completion1 Jan 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984575
- Sponsor's protocol ID
- stress and hyperuricemia
- Status last verified
- May 2025
- First submitted
- 21 Feb 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Intestinal Flora Changes and Hyperuricemia Under Chronic Psychological Stress
- ClinicalTrials.gov ID
- NCT06984575
- Acronym / sponsor ID
- stress and hyperuricemia
- Conditions
- Hyperuricemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 22 May 2025 (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 clarify the mechanism of stress on the incidence of hyperuricemia
Detailed description
To clarify the differences in intestinal microorganisms and metabolism between healthy people and hyperuricemia patients and across different level of stress
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LSC | – | Other: No interventionshealthy people with low level of stress |
| HSC | – | Other: No interventionshealthy people with high level of stress |
| LSH | – | Other: No interventionshyperuricemia patients with low level of stress |
| HSH | – | Other: No interventionshyperuricemia patients with high level of stress |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hyperuricemia patients and healthy controls
Key inclusion criteria (3 listed)
- Obtain the informed consent of the subjects before conducting any trial-related activities;
- Males aged 18-69;
- The hyperurcemia group must meet the diagnostic criteria of having blood uric acid >420umol/L measured twice on an empty stomach on different days under a normal purine diet;
Key exclusion criteria (2 listed)
- 1)Use of any uric acid-lowering drugs, anti-gout drugs, steroids, proton pump inhibitors, or non-steroidal anti-inflammatory drugs within one month before enrollment; 2)Use of any antibiotics, probiotics, or other drugs including traditional Chinese medicine within one month before enrollment; 3)Abnormal liver function, ALT and AST are more than 2.5 times the upper limit of normal; 4)Other diseases that affect glucose and lipid metabolism: hyperthyroidism, hypothyroidism, hypercortisolism, etc.
- 5)Chronic kidney disease or severe renal impairment, according to eGFR grading <45mL/min/1.73m2; 6)Secondary hyperuricemia 7)Any gastrointestinal diseases
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 interventionsNo interventions | Other | HSC, HSH, LSC, LSH |
Primary outcome
Phenotype differences in the gut microbiome by metagenomic sequencing.
Time frame: Samples to be collected once per participant within 7 days of enrollment
including microbial composition analysis(Taxonomic Annotation Tools: MetaPhlAn4; Functional Gene Analysis Tools:eggNOG-mapper (functional classification) and diversity metrics(α-diversity (Shannon index) and β-diversity (Bray-Curtis distance, UniFrac distance)
sequencing results of the fecal metabolome in the population
Time frame: Samples to be collected once per participant within 7 days of enrollment
1 secondary outcome
Serum uric acid
Time frame: Samples to be collected once per participant within 7 days of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hyperuricemia, run by Shanghai 10th People's Hospital 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 22 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotype differences in the gut microbiome by metagenomic sequencing. (time frame: Samples to be collected once per participant within 7 days of enrollment). The study lists 2 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 22 May 2025.