FIB-4 Cut-Offs for Liver Fibrosis in Obese Endocrinology Patients (OBEMASLD)
Assessment of the Accuracy of FIB-4 Cut-Offs for the Prediction of Liver Fibrosis in Obese Patients Attending Endocrinology Clinics in Italy
This single-center, prospective observational study aims to assess the accuracy of FIB-4 cut-offs in identifying liver fibrosis in obese patients attending an endocrinology outpatient clinic in Italy.
All consecutive eligible patients undergo routine blood tests and liver elastography (FibroScan) as part of clinical practice; FIB-4 values will be calculated and compared with liver stiffness measurements to evaluate the performance of FIB-4 thresholds for directing patients to FibroScan and hepatology care.
調査の概要
状態
条件
詳細な説明
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a frequent complication of metabolic syndrome and obesity and may progress to advanced fibrosis, cirrhosis and hepatocellular carcinoma.
Recent EASL-EASD-EASO guidelines recommend the use of the FIB-4 score as a first-line non-invasive tool to stratify the risk of advanced fibrosis in patients with metabolic risk factors, including those with obesity.
However, current FIB-4 cut-offs may lead to a high number of positive cases and an important burden of further liver stiffness assessment.
This study will prospectively enroll obese patients referred to the Clinical Nutrition Center for the Research and Care of Obesity and Metabolic Diseases at IRCCS "Saverio de Bellis".
During a Day Service access, patients undergo routine blood tests and FibroScan; FIB-4 is calculated using age, AST, ALT and platelet count.
Patients will be classified according to FIB-4 (≥1.3 vs <1.3), and FIB-4 performance in predicting liver fibrosis, as assessed by liver stiffness, will be evaluated using correlation analyses, Bland-Altman plots, agreement measures and ROC curves.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Vincenza Di Stasi, MD
- 電話番号：+39 0804994669
- メール：vincenza.distasi@irccsdebellis.it
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:
- Obesity class I or II (body mass index, BMI ≥ 30 kg/m² and ≤ 40 kg/m²)
- Age > 18 years and < 65 years.
- Ability to provide written informed consent after adequate information on the study objectives.
- Arm 1: patients with FIB-4 ≥ 1.3.
- Arm 2: patients with FIB-4 < 1.3.
Exclusion Criteria:
- Lack of signed informed consent.
- Pregnancy or breastfeeding.
- Known liver diseases that rule out MASLD (MetALD, alcoholic liver disease, liver cirrhosis, hepatocellular carcinoma, viral hepatitis, autoimmune hepatitis).
- Current treatment with anti-obesity or type 2 diabetes medications with a known effect on hepatic steatosis (Semaglutide or Tirzepatide).
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 |
|---|
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High FIB-4
Obese patients with FIB-4 ≥ 1.3 undergoing FibroScan as part of clinical practice.
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Low FIB-4
Obese patients with FIB-4 < 1.3 undergoing FibroScan as part of clinical practice
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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 |
|---|---|---|
|
Accuracy of current FIB-4 cut-offs in directing obese patients to FibroScan for the diagnosis of liver fibrosis
時間枠：At baseline evaluation (Day Service visit)
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Diagnostic accuracy (sensitivity, specificity, predictive values, ROC-AUC) of FIB-4 thresholds (e.g.
1.3) for the prediction of liver fibrosis as defined by liver stiffness measurements obtained by FibroScan.
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At baseline evaluation (Day Service visit)
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gomez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. J Hepatol. 2023 Dec;79(6):1542-1556. doi: 10.1016/j.jhep.2023.06.003. Epub 2023 Jun 24.
- European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). J Hepatol. 2024 Sep;81(3):492-542. doi: 10.1016/j.jhep.2024.04.031. Epub 2024 Jun 7.
- Silverii GA, Profili F, Francesconi P, Mannucci E. Fibrosis-4 score for screening of metabolic dysfunction-associated steatotic liver disease (MASLD): Data from a population-based sample in Tuscany. Nutr Metab Cardiovasc Dis. 2024 Oct;34(10):2405-2408. doi: 10.1016/j.numecd.2024.05.016. Epub 2024 May 15.
研究記録日
主要日程の研究
研究開始 (推定)
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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