Clinical trial NCT03151473: Longitudinal Observational Study Of Chinese With NAFLD/NASH
Official title: Prospective Cohort Assessing The Prevalence And Progress Of Non-Alcoholic Fatty Liver Disease (NAFLD)/Non-Alcoholic Steatohepatitis (NASH) In Chinese Subjects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Alcoholic Fatty Liver Disease (NAFLD)
Non-Alcoholic Steatohepatitis (NASH)
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects (BMI ≥ 25 kg/m2) with proven NAFL/NASH either by imaging (using MRI) or histology, referred to secondary or tertiary care for liver related problems will be asked to participate in this study.

Brief summary: This is a 10-year, longitudinal, observational study of patients with NAFLD/NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, the biospecimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.

Detailed description: Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver cells. It is associated with obesity, high blood pressure, high cholesterol, and diabetes. Some people with NAFLD only have excess fat in the liver. However, other people may develop a worse form of NAFLD with liver injury and scarring. This form, called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer, and death. Not much is known about why some people develop NASH and others do not.

This study aims to determine and elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications in Chinese subjects.

Eligibility criteria: Inclusion Criteria:

* Males or females aged 18 and older;
* Adults being managed or treated for NAFL or NASH;
* Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.

Exclusion Criteria:

* Incompetent to understand and/or sign the informed consent;
* Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female;
* Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson's disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis
* Diagnosis of liver cirrhosis and/or hepatocellular carcinoma;
* Diagnosis of chronic inflammatory disease (i.e. inflammatory bowel disease, rheumatoid arthritis, inflammatory lung disease, severe infectious diseases), other than NAFL/NASH.

Primary outcomes:
measure: Prevalence of NAFL/NASH in Chinese
timeFrame: up to 10 years
Secondary outcomes:
measure: Live imaging analysis
timeFrame: up to 10 years
measure: Exploration, identification and validation of the circulating biomarkers for prediction and diagnosis of NAFL/NASH in Chinese
timeFrame: up to 10 years
measure: Liver histology analysis
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Humanity and Health Medical Centre
Study officials:
References: