Nonalcoholic Fatty Liver DiseaseNCT05625750
Observational Study About Patients Diagnosed With NAFLD
An observational study of Nonalcoholic Fatty Liver Disease, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Nonalcoholic fatty liver disease (NAFLD) is the most common condition affecting the liver, owing to its association with obesity and the metabolic syndrome. The largest study to date using magnetic resonance spectroscopy to quantify liver triglyceride (TG) content showed that approximately 33% of individuals have… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2022to 27 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients between the age of 18-75, who was diagnosed with NAFLD were all elligible for this observational study.
Who may be able to join
- 1. patients diagnosed with nonalcoholic fatty liver disease
Who cannot join
- patients suspected of excessive alcohol consumption
- malignant tumors, dementia, active tuberculosis, AIDS, organ failure, pregnancy or breastfeeding, etc cannot cooperate with the investigation
- incomplete data such as HBV serological results and abdominal ultrasound results
- patients who refuse to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Infectious Disease, Xiangya Hospital, Central South University
Changsha, Hunan, 410008
Yan Huang, +86 13874854142, ganrankedrhyan@163.com
About this study
Official title: Study on the Characteristic, Therapy and Prognosis of Patients With Nonalcoholic Fatty Liver Disease
Nonalcoholic fatty liver disease (NAFLD) is the most common condition affecting the liver, owing to its association with obesity and the metabolic syndrome. The largest study to date using magnetic resonance spectroscopy to quantify liver triglyceride (TG) content showed that approximately 33% of individuals have hepatic steatosis. NAFLD encompasses a continuum of histological findings that starts with steatosis that can progress to nonalcoholic steatohepatitis (NASH), which is characterized by inflammation and cell death, and eventually cirrhosis. Given the large number of individuals afflicted with this condition, there is a clear need to develop effective and safe therapies to treat NAFLD.
Read the detailed description
Patients with NAFLD were recruited in the current study and divided into NAFLD group, and NASH group. The researchers will collect various clinical examination indexes of the subjects in the process of diagnosis and treatment, including but not limited to ALT, AST, TG, TC, etc. Characteristic and prognosis of patients will be recorded. The serum, feces, urine and liver (if necessary) samples of all subjects will be taken after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects.
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- Nonalcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
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 |
|---|---|---|
| Patients diagnosed with NAFLD | All subjects will receive the currently recognized routine test of NAFLD according to their disease and no additional intervention and treatment will be added for subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
BMI stands for body mass index. This is the ratio of a person's height to their weight.
Measured: 3 weeks
alcohol intake
alcohol consumption every week
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start27 Apr 2022
- Primary completion27 Apr 2025 (estimated)
- Study completion27 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Yan, Xiangya Hospital of Central South University
- Investigators
- Yan Huang, Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625750
- Sponsor's protocol ID
- Xiangya NAFLD project
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang S, Zhu Q, Liang G, Franks T, Boucher M, Bence KK, Lu M, Castorena CM, Zhao S, Elmquist JK, Scherer PE, Horton JD. Cannabinoid receptor 1 signaling in hepatocytes and stellate cells does not contribute to NAFLD. J Clin Invest. 2021 Nov 15;131(22):e152242. doi: 10.1172/JCI152242.
PubMed 34499619
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Characteristic, Therapy and Prognosis of Patients With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05625750
- Acronym / sponsor ID
- Xiangya NAFLD project
- Conditions
- Nonalcoholic Fatty Liver Disease
- Keywords
- Nonalcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 27 Apr 2025 (estimated)
- Study completion
- 27 Apr 2027 (estimated)
- First posted
- 23 Nov 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.
Nonalcoholic fatty liver disease (NAFLD) is the most common condition affecting the liver, owing to its association with obesity and the metabolic syndrome. The largest study to date using magnetic resonance spectroscopy to quantify liver triglyceride (TG) content showed that approximately 33% of individuals have hepatic steatosis. NAFLD encompasses a continuum of histological findings that starts with steatosis that can progress to nonalcoholic steatohepatitis (NASH), which is characterized by inflammation and cell death, and eventually cirrhosis. Given the large number of individuals afflicted with this condition, there is a clear need to develop effective and safe therapies to treat NAFLD.
Detailed description
Patients with NAFLD were recruited in the current study and divided into NAFLD group, and NASH group. The researchers will collect various clinical examination indexes of the subjects in the process of diagnosis and treatment, including but not limited to ALT, AST, TG, TC, etc. Characteristic and prognosis of patients will be recorded. The serum, feces, urine and liver (if necessary) samples of all subjects will be taken after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with NAFLD | – | –All subjects will receive the currently recognized routine test of NAFLD according to their disease and no additional intervention and treatment will be added for subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the age of 18-75, who was diagnosed with NAFLD were all elligible for this observational study.
Key inclusion criteria (1 listed)
- 1. patients diagnosed with nonalcoholic fatty liver disease
Key exclusion criteria (4 listed)
- patients suspected of excessive alcohol consumption
- malignant tumors, dementia, active tuberculosis, AIDS, organ failure, pregnancy or breastfeeding, etc cannot cooperate with the investigation
- incomplete data such as HBV serological results and abdominal ultrasound results
- patients who refuse to sign informed consent
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
BMI
Time frame: 3 weeks
BMI stands for body mass index. This is the ratio of a person's height to their weight.
alcohol intake
Time frame: 3 years
alcohol consumption every week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Background: PubMed 34499619Wang S, Zhu Q, Liang G, Franks T, Boucher M, Bence KK, Lu M, Castorena CM, Zhao S, Elmquist JK, Scherer PE, Horton JD. Cannabinoid receptor 1 signaling in hepatocytes and stellate cells does not contribute to NAFLD. J Clin Invest. 2021 Nov 15;131(22):e152242. doi: 10.1172/JCI152242.
- 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.
Yan Huang study director
Xiangya Hospital of Central South 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 Nonalcoholic Fatty Liver Disease, run by Xiangya Hospital of Central South 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 4 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: looking for participants now, as of the sponsor's last update on 30 Nov 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Huang (+86 13874854142, ganrankedrhyan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: 3 weeks). 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?
On the ClinicalTrials.gov record for NCT05625750, which also lists 1 linked publication.
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 30 Nov 2022.