NAFLDNCT03534908
Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study
An observational study of NAFLD and Cardiovascular Diseases, run by Wuhan University at 1 site in China.
Trial summary
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the world. NAFLD is associated with a lot of comorbidity, such as diabetes, metabolic syndrome, coronary heart disease and chronic kidney diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Cardiovascular Diseases
- How many people
- 5,000,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2017to 30 Jun 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People who have taken medical examination and health checkup in the health management centers of hospitals in China.
Who may be able to join
- males or females aged 18-75
Who cannot join
- malignancy except primary liver cancer
- pregnancy or breastfeeding
- liver diseases of other etiology including hepatitis C virus infection ,autoimmune hepatitis,Wilson's disease,hemachromatosis,drug-induced hepatitis,parenteral nutrition
- excessive alcohol consumption
- cases missing crucial data
Trial locations and contacts
1 site in 1 country.
About this study
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the world. NAFLD is associated with a lot of comorbidity, such as diabetes, metabolic syndrome, coronary heart disease and chronic kidney diseases. However, the correlation between the NAFLD and cardiovascular disease (CVD) events remains controversial. This study is an observational study based on a big retrospective cohort in china to explore the prevalence of NAFLD in China, the risk factors associated with NAFLD, as well as whether patients with NAFLD are more prone to experience CVDs and CVD events.
- Conditions
- NAFLD, Cardiovascular Diseases
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NAFLD group | those with NAFLD | |
| Control group | those without NAFLD |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of NAFLD in China
Measured: June，2020
Secondary outcomes (2)
the risk factors associated with NAFLD
Measured: August，2020
to indicate the prevalence of CVDs and CVD events in people with and without NAFLD
Measured: October，2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start25 Sep 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies 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
- Retrospective
- Enrolment
- 5,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongliang Li, Wuhan University
- Investigators
- Hongliang Li, MD,PhD, Principal investigator, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534908
- Sponsor's protocol ID
- WDRY2017-K009
- Status last verified
- Oct 2019
- First submitted
- 11 May 2018
- Last updated
- 8 Oct 2019
- 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 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study
- ClinicalTrials.gov ID
- NCT03534908
- Acronym / sponsor ID
- WDRY2017-K009
- Conditions
- NAFLD, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000,000 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 23 May 2018 (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.
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the world. NAFLD is associated with a lot of comorbidity, such as diabetes, metabolic syndrome, coronary heart disease and chronic kidney diseases. However, the correlation between the NAFLD and cardiovascular disease (CVD) events remains controversial. This study is an observational study based on a big retrospective cohort in china to explore the prevalence of NAFLD in China, the risk factors associated with NAFLD, as well as whether patients with NAFLD are more prone to experience CVDs and CVD events.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAFLD group | – | –those with NAFLD |
| Control group | – | –those without NAFLD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who have taken medical examination and health checkup in the health management centers of hospitals in China.
Key inclusion criteria (1 listed)
- males or females aged 18-75
Key exclusion criteria (5 listed)
- malignancy except primary liver cancer
- pregnancy or breastfeeding
- liver diseases of other etiology including hepatitis C virus infection ,autoimmune hepatitis,Wilson's disease,hemachromatosis,drug-induced hepatitis,parenteral nutrition
- excessive alcohol consumption
- cases missing crucial data
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 prevalence of NAFLD in China
Time frame: June，2020
2 secondary outcomes
the risk factors associated with NAFLD
Time frame: August，2020
to indicate the prevalence of CVDs and CVD events in people with and without NAFLD
Time frame: October，2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- 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.
Hongliang Li, MD,PhD principal investigator
Wuhan 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 NAFLD and Cardiovascular Diseases, run by Wuhan University 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 1 inclusion and 5 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 Oct 2019. 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?
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 prevalence of NAFLD in China (time frame: June，2020). 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 Oct 2019.