Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

Обзор

\- Determination of sarcopenia frequency among patients with metabolic dysfunction-associated steatotic liver disease 2- Exploring the association of sarcopenia with disease state (steatosis grade and fibrosis) among patients with metabolic dysfunction-associated steatotic liver disease

Подробное описание

Metabolic dysfunction-associated steatotic liver disease (MASLD) is recognized as the most common cause of chronic liver disease, with the most recent meta-analysis suggesting that more than 38% of the world's adult population and up to 14% of paediatric population are affected \[1\].

Sarcopenia is defined as the degenerative loss of skeletal muscle mass, strength, and function with age \[2\]. While sarcopenia predominantly targets older demographics, it can also manifest in younger populations under certain circumstances such as prolonged periods of physical inactivity, severe malnutrition or eating disorders, and chronic diseases that affect muscle mass and function, like cancer \[3\]. Prevalence rates up to 13% in those aged 60-70, escalating to 50% in individuals over 80, with an accelerated decline in muscle mass beginning around 50 years of age and strength at 65 were reported \[4\].

Emerging evidence suggests that sarcopenia may not only be a consequence of MASLD progression but also a contributing factor to disease development and severity. Patients with MASLD exhibit a significantly higher prevalence of sarcopenia compared to healthy controls, with odds ratios ranging from 1.25 to 2.08 \[5,6\]. MASLD and sarcopenia have several risk factors in common such as insulin resistance (IR) \[7\].

Our study aims to explore the relation between sarcopenia MASLD progression. Such a conflict was a provocation for a research question to answer if there is a relation between sarcopenia and MASLD progression.

Первичные конечные точки

• Sarcopenia in metabolic dysfunction-associated steatotic liver disease [Срок оценки: 1 year]

Вторичные конечные точки (1)

• Sarcopenia in metabolic dysfunction-associated steatotic liver disease [Срок оценки: 1 year]

Критерии участия

Критерии включения

The study is intended to include adult patients with metabolic dysfunction-associated steatotic liver disease which will be diagnosed based on imaging study plus one of the following criteria \[8\]:

• BMI ≥ 25 kg/m2 or waist circumference > 94 cm in men, > 80 cm in women
• Fasting serum glucose ≥ 100 mg/dL (≥ 5.6 mmol/L) or 2-hour post-load glucose level ≥ 140 mg/dL (≥ 7.8 mmol/L) or hemoglobin A1C (HbA1C) ≥ 5.7% or on specific drug treatment
• Blood pressure ≥ 130/85 mmHg or specific drug treatment
• Plasma triglycerides ≥ 150 mg/dL (≥ 1.70 mmol/L) or specific drug treatment
• Plasma high-density lipoprotein (HDL)-cholesterol < 40 mg/dL (< 1.0 mmol/L) for men and < 50 mg/dL (< 1.3 mmol/L) for women or specific drug treatment For significant steatosis grading, hepatic steatosis index (HSI) will be used (BMI, diabetes mellitus, and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio; cut-off score: >36). \[9\].

For significant fibrosis staging, both liver stiffness measurement and several fibrosis scores will be used. Fibrosis scores will include NAFLD fibrosis score (BMI, age, hyperglycemia, AST/ALT ratio, albumin, and platelet count; cut-off score: ≥ 0.675) \[9\].

Критерии исключения

• Age less than 18 years old or more than 65 years old
• Pregnant patients
• Chronic hepatitis C virus and/or hepatitis B virus infection
• Any alcohol consumption
• Autoimmune hepatitis
• Hepatic and/or extrahepatic neoplastic disorders
• Medication and/or substance use which may lead to hepatic steatosis and/or injury
• Eating disorders
• Comorbidities such as neuromuscular, pulmonary, and renal disorders
• Use of anabolic steroids

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10 PMID 32033882
• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48( PMID 30312372
• Indre MG, Leucuta DC, Lupsor-Platon M, Turco L, Ferri S, Hashim A, Orasan OH, Procopet B, Stefanescu H, Morelli MC, Piscaglia F, Ravaioli F. Diagnostic accuracy of 2D-SWE ultrasound for liver fibrosis assessment in MASLD: A multilevel random effects model meta-analysis. Hepatology. 2025 Aug 1;82(2):454-469. doi: 10.1097/HEP.0000000000001190. Epub 2024 Dec 16. PMID 39689354
• Hernaez R, Lazo M, Bonekamp S, Kamel I, Brancati FL, Guallar E, Clark JM. Diagnostic accuracy and reliability of ultrasonography for the detection of fatty liver: a meta-analysis. Hepatology. 2011 Sep 2;54(3):1082-1090. doi: 10.1002/hep.24452. PMID 21618575
• Kouvari M, Valenzuela-Vallejo L, Guatibonza-Garcia V, Polyzos SA, Deng Y, Kokkorakis M, Agraz M, Mylonakis SC, Katsarou A, Verrastro O, Markakis G, Eslam M, Papatheodoridis G, George J, Mingrone G, Mantzoros CS. Liver biopsy-based validation, confirmation and comparison of the diagnostic performance of established and novel non-invasive steatotic liver disease indexes: Results from a large multi-c PMID 37527759
• 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, Mo PMID 37364790
• Li AA, Kim D, Ahmed A. Association of Sarcopenia and NAFLD: An Overview. Clin Liver Dis (Hoboken). 2020 Sep 4;16(2):73-76. doi: 10.1002/cld.900. eCollection 2020 Aug. No abstract available. PMID 32922754
• Malik A, Javaid S, Malik MI, Qureshi S. Relationship between sarcopenia and metabolic dysfunction-associated steatotic liver disease (MASLD): A systematic review and meta-analysis. Ann Hepatol. 2024 Nov-Dec;29(6):101544. doi: 10.1016/j.aohep.2024.101544. Epub 2024 Aug 29. PMID 39214253

Идентификаторы

NCT: NCT07598916 · Sarcopenia in MASLD patient

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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