Great China Fatter Liver Consortium (GC_FLC) Study to Assess the Progress of NAFLD/NASH in Chinese

Launched by GREAT CHINA FATTY LIVER CONSORTIUM LIMITED · Sep 12, 2017

Keywords

ClinConnect Summary

The Great China Fatter Liver Consortium (GC_FLC) Study is researching a liver condition called Nonalcoholic Fatty Liver Disease (NAFLD) and its more serious form, Nonalcoholic Steatohepatitis (NASH), particularly in Chinese patients. NAFLD is when fat builds up in the liver without alcohol being the cause, and NASH can lead to liver damage and serious health issues. This study aims to compare non-invasive methods of assessing liver health against the traditional liver biopsy, which is a more invasive procedure. By following participants for up to 10 years, researchers hope to better understand how these conditions progress over time.

To participate in this study, individuals must be at least 6 years old and have a diagnosis of NAFLD or NASH. This includes adults and children who can understand and agree to participate. However, those with certain liver diseases, significant alcohol consumption, or who have had specific surgeries may not qualify. Participants can expect regular check-ups and assessments to monitor their liver health without needing frequent biopsies. This study is important because it could help improve how doctors diagnose and treat these liver conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults and children subjects aged \>= 6 years old
• • Ability to understand and sign a written informed consent form (ICF) or provide assent in pediatric subjects
• * Diagnosis of NAFLD; or a definite or probable diagnosis of NASH:
• • 1. A diagnosis of NAFLD will be defined by evidence of hepatic steatosis, either by imaging or by histology, with no causes for secondary hepatic fat accumulation such as significant alcohol consumption, use of steato-genic medication (e.g. valproate, amiodarone, anti-retroviral medications, tetracycline, chronic high-dose corticosteroids), or hereditary disorders (e.g. Wilson's disease, Wolman disease, cholesteryl-ester storage disease);
• • 2. A definite diagnosis of NASH will be defined by steatohepatitis confirmed by biopsy with correlating clinical evidence of non-alcoholic liver disease;
• 3. A probable diagnosis of NASH will be defined by:
• • a.Elevated alanine amino transferase levels (ALT) of \>40 U/L; and b.Evidence of hepatic steatosis on imaging; or c.Obesity, type 2 diabetes, or pre-diabetes. Pre-diabetes is defined by: i.Impaired fasting glucose: 100 mg/dL-125 mg/dL (5.6 mmol/L-6.9 mmol/L) or; ii.Impaired glucose tolerance: 2-hr plasma glucose (PG) in 75-g Oral Glucose Tolerance Test (OGTT) 140 mg/dL-199 mg/dL (7.8 mmol/L-11.0 mmol/L) or; iii.HbA1C: 5.7%-6.4%.
• Exclusion Criteria:
• • Unable to provide written informed consent (or assent in pediatric subjects)
• • Alcohol consumption greater than 21 units/week for males or 14 units/week for females (one unit of alcohol is half pint of beer \[285 mL; 9.64 oz\], 1 glass of spirits \[25 mL; 0.85 oz\] or 1 glass of wine \[125 mL; 4.23 oz\]
• • Enrolled in NASH-related clinical trials
• * Presence of other forms of chronic liver disease:
• • 1. Chronic hepatitis B (HBsAg positive)
• • 2. Chronic hepatitis C (HCV RNA positive)
• • 3. Iron overload disorders (3-4+ iron on liver biopsy or known hemochromatosis gene (HFE) C282Y homozygous with ferritin \> 200 ng/ml; note: an elevated ferritin alone is common in NASH and is not exclusionary)
• • 4. Autoimmune liver disease (biopsy evidence or clinical diagnosis of autoimmune hepatitis or Primary biliary cholangitis (PBC) requiring ongoing treatment, imaging evidence of Primary sclerosing cholangitis (PSC))
• • 5. Wilson's disease
• • 6. Alpha-1 antitrypsin mutations that in the opinion of the principal investigator is contributing to the patient's liver disease;
• • Prior bariatric surgery unless the surgery was performed more than one year before the biopsy diagnosis of NASH (i.e., NASH is present despite prior bariatric surgery);
• • Planned bariatric surgery (e.g. gastroplasty, roux-en-Y gastric bypass).