Non-Alcoholic Fatty Liver DiseaseNCT05245890
Assocaiton Between Uric Acid Trajecteries and Remission of NAFLD in NAFLD Individuals
An observational study of Non-Alcoholic Fatty Liver Disease and Hyperuricemia, run by Ningbo No. 1 Hospital.
Trial summary
Uric acid is the end product of dietary or endogenous purines degradation, and hyperuricemia is one of the most common metabolic disorders. A growing body of evidence, comprising a great deal of cross-sectional studies and several prospective ones, also indicates that hyperuricemia is associated with increased… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Hyperuricemia
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Mar 2024
- How long will I take part?
- 2 Years
- 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 80 years
- All sexes
- Adult, Older adult
Study population: People who undergo annual physical examinations in The First Affiliated Hospital, College of Medicine, Zhejiang University are enrolled in this study. People are divided into two groups according to hepatic ultrasonic examination at baseline: (1) individuals with NAFLD; (2) individuals without NAFLD.
Who may be able to join
- age >=18 years;
- agree to be enrolled in this study.
Who cannot join
- those taking antihypertensive or antidiabetic agents, lipid-lowing agents, or hypouricemic agents;
- those with alcohol consumption greater than 140 g/week for men and 70 g/week for women;
- those with a history of other known causes of chronic liver disease such as viral hepatitis or autoimmune hepatitis, and those using hepatotoxic medications.
About this study
Official title: Assocaiton Between Uric Acid Trajecteries and Remission of Non-alcoholic Fatty Liver Disease (NAFLD) in NAFLD Individuals
Uric acid is the end product of dietary or endogenous purines degradation, and hyperuricemia is one of the most common metabolic disorders. A growing body of evidence, comprising a great deal of cross-sectional studies and several prospective ones, also indicates that hyperuricemia is associated with increased prevalence, incidence, and disease severity of non-alcoholic fatty liver disease (NAFLD).
Capitalizing on a cohort study in China, the investigators are aimed to assess the associations of SUA trajecteries with remission of NAFLD in NAFLD individuals and examined whether the association differs across subpopulations.
Read the detailed description
A cohort study was conducted to evaluate the relationship between the SUA trajecteries and remission of NAFLD. The study enrolled employees who were attending their annual health examination. Furrhermore, the investigators are aimed to explore whether the association differs across subpopulations.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Hyperuricemia
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hyperuricemia
What is being measured
The primary outcome is the main question the study is designed to answer.
the severity fatty liver evaluated by hepatic ultrasonic examination
Hepatic ultrasonic examination was performed in all subjects by a trained ultrasonographist who was unaware of the clinical and laboratory data. Hepatic steatosis was diagnosed by characteristic echo patterns according to conventional criteria, such as the evidence of diffuse hyperechogenicity of the liver relative to the kidneys, ultrasound beam attenuation, and poor visualization of intrahepatic structures.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Afliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245890
- Sponsor's protocol ID
- uric acid trajecteries2022
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assocaiton Between Uric Acid Trajecteries and Remission of Non-alcoholic Fatty Liver Disease (NAFLD) in NAFLD Individuals
- ClinicalTrials.gov ID
- NCT05245890
- Acronym / sponsor ID
- uric acid trajecteries2022
- Conditions
- Non-Alcoholic Fatty Liver Disease, Hyperuricemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Collaborators
- The First Afliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 18 Feb 2022 (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.
Uric acid is the end product of dietary or endogenous purines degradation, and hyperuricemia is one of the most common metabolic disorders. A growing body of evidence, comprising a great deal of cross-sectional studies and several prospective ones, also indicates that hyperuricemia is associated with increased prevalence, incidence, and disease severity of non-alcoholic fatty liver disease (NAFLD).
Capitalizing on a cohort study in China, the investigators are aimed to assess the associations of SUA trajecteries with remission of NAFLD in NAFLD individuals and examined whether the association differs across subpopulations.
Detailed description
A cohort study was conducted to evaluate the relationship between the SUA trajecteries and remission of NAFLD. The study enrolled employees who were attending their annual health examination. Furrhermore, the investigators are aimed to explore whether the association differs across subpopulations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People who undergo annual physical examinations in The First Affiliated Hospital, College of Medicine, Zhejiang University are enrolled in this study. People are divided into two groups according to hepatic ultrasonic examination at baseline: (1) individuals with NAFLD; (2) individuals without NAFLD.
Key inclusion criteria (2 listed)
- age >=18 years;
- agree to be enrolled in this study.
Key exclusion criteria (3 listed)
- those taking antihypertensive or antidiabetic agents, lipid-lowing agents, or hypouricemic agents;
- those with alcohol consumption greater than 140 g/week for men and 70 g/week for women;
- those with a history of other known causes of chronic liver disease such as viral hepatitis or autoimmune hepatitis, and those using hepatotoxic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the severity fatty liver evaluated by hepatic ultrasonic examination
Time frame: 2 years
Hepatic ultrasonic examination was performed in all subjects by a trained ultrasonographist who was unaware of the clinical and laboratory data. Hepatic steatosis was diagnosed by characteristic echo patterns according to conventional criteria, such as the evidence of diffuse hyperechogenicity of the liver relative to the kidneys, ultrasound beam attenuation, and poor visualization of intrahepatic structures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Hyperuricemia, run by Ningbo No. 1 Hospital.
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 2 inclusion and 3 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 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
the severity fatty liver evaluated by hepatic ultrasonic examination (time frame: 2 years). 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 18 Feb 2022.