Clinical Course and Biomarkers Associated With Nonalcoholic Fatty Liver Disease (NAFLD) in Chinese Patients With Obesity
Nonalcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease in many parts of the world. NAFLD can progress to nonalcoholic steatohepatitis (NASH) and result in cirrhosis and liver cancer. Despite NAFLD is common, there are a lot of knowledge gaps about this common disease including the progression from NAFLD to NASH and from fibrosis to cirrhosis, efficacious treatment strategies, etc.
In this study, we aim to investigate the clinical course and biomarkers associated with NAFLD in a group of obese patients with or without known history of NAFLD at baseline undergoing laparoscopic bariatric surgery. During laparoscopic surgery, subjects consented to participate will have liver biopsies performed under direct vision and sent for histological analysis and scoring. The patients will undergo comprehensive clinical and biochemical assessment before and after the surgical procedures.
The prevalence of NAFLD and clinical course of this group of patients with obesity will be assessed using histology as the gold standard. Clinical characteristics and biomarkers associated with NAFLD will be identified.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Alice Pik Shan Kong, MD
- Telefonnummer: +852 3505 2648
- E-mail: alicekong@cuhk.edu.hk
Studiesteder
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New Territories
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Hong Kong, New Territories, Hong Kong, 99977
- Rekruttering
- Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital
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Kontakt:
- Alice Pik Shan Kong, MD
- Telefonnummer: +852 3505 2648
- E-mail: alicekong@cuhk.edu.hk
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age 18 years or above
- Chinese ethnicity
- Patient undergoing obesity surgery at The Prince of Wales Hospital
Exclusion Criteria:
- Endocrine causes of obesity
- Active uncontrolled psychiatric illness
- Active substance abuse
- Alcohol intake exceeding 30 grams per day in males or 20 grams per day in females
- Presence of other co-existing liver disease, as evidenced by known history of positive viral hepatitis serology
- History of decompensated liver disease
- Unlikely to comply with management protocol
- Failure to give consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Control
Obese cases without NAFLD
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Obese cases with NAFLD
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of NAFLD and NASH at baseline, based on histological assessment
Tidsramme: Baseline
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Histological scoring of NAFLD will be based on the Brunt's system.20
In brief, liver steatosis is graded from 0 to 3, necroinflammation graded from 0 to 3, and fibrosis staged from 0 to 4. Nonalcoholic steatohepatitis (NASH) is defined as necroinflammatory grade 2/3 and/or fibrosis stage ≥1.
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Baseline
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The clinical course predicting NAFLD and NASH in this cohort
Tidsramme: 1 year
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Including fibroscan and liver enzymes
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1 year
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Correlation between serum alanine aminotransferase and histological severity
Tidsramme: 1 year
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1 year
|
|
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Biomarkers predicting NAFLD and NASH in this cohort
Tidsramme: 1 year
|
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1 year
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018.386
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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