Observational Study About Patients Diagnosed With NAFLD
Study on the Characteristic, Therapy and Prognosis of Patients With Nonalcoholic Fatty Liver Disease
1 other identifier
observational
500
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 27, 2022
CompletedFirst Submitted
Initial submission to the registry
November 15, 2022
CompletedFirst Posted
Study publicly available on registry
November 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2027
ExpectedNovember 30, 2022
November 1, 2022
3 years
November 15, 2022
November 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
BMI
BMI stands for body mass index. This is the ratio of a person's height to their weight.
3 weeks
alcohol intake
alcohol consumption every week
3 years
Study Arms (1)
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
Eligibility Criteria
Patients between the age of 18-75, who was diagnosed with NAFLD were all elligible for this observational study.
You may qualify if:
- \. patients diagnosed with nonalcoholic fatty liver disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Infectious Disease, Xiangya Hospital, Central South University
Changsha, Hunan, 410008, China
Related Publications (1)
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.
PMID: 34499619BACKGROUND
Biospecimen
whole blood including blood cells, serum and plasma, urine, faeces and liver tissue (if necessary)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yan Huang
Xiangya Hospital of Central South University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 15, 2022
First Posted
November 23, 2022
Study Start
April 27, 2022
Primary Completion
April 27, 2025
Study Completion (Estimated)
April 27, 2027
Last Updated
November 30, 2022
Record last verified: 2022-11