Relationship Between Intestinal Flora Changes and Hyperuricemia Under Chronic Psychological Stress

NCT06984575 | Completed

• 1 other identifier: stress and hyperuricemia
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

To clarify the mechanism of stress on the incidence of hyperuricemia

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (2)

• 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)

  Samples to be collected once per participant within 7 days of enrollment

• sequencing results of the fecal metabolome in the population

  Samples to be collected once per participant within 7 days of enrollment

Secondary Outcomes (1)

• Serum uric acid

  Samples to be collected once per participant within 7 days of enrollment

Study Arms (4)

LSC

healthy people with low level of stress

Other: No interventions

HSC

healthy people with high level of stress

Other: No interventions

LSH

hyperuricemia patients with low level of stress

Other: No interventions

HSH

hyperuricemia patients with high level of stress

Other: No interventions

Interventions

No interventions OTHER

No interventions

HSC; HSH; LSC; LSH

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hyperuricemia patients and healthy controls

You may qualify if:

• 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;

You may not qualify if:

• \- 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.
• )Chronic kidney disease or severe renal impairment, according to eGFR grading \<45mL/min/1.73m2; 6)Secondary hyperuricemia 7)Any gastrointestinal diseases

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's hospital

Shanghai, Shanghai Municipality, 200070, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum Sample Collection# and Stool specimen collection

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: May 22, 2025
• Study Start: September 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

CN (1)