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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Alice Pik Shan Kong, MD
- 電話番号：+852 3505 2648
- メール：alicekong@cuhk.edu.hk
研究場所
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New Territories
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Hong Kong、New Territories、香港、99977
- 募集
- 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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コンタクト：
- Alice Pik Shan Kong, MD
- 電話番号：+852 3505 2648
- メール：alicekong@cuhk.edu.hk
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Control
Obese cases without NAFLD
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Obese cases with NAFLD
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Prevalence of NAFLD and NASH at baseline, based on histological assessment
時間枠：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
時間枠：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
時間枠：1 year
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1 year
|
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Biomarkers predicting NAFLD and NASH in this cohort
時間枠：1 year
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1 year
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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