Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver Disease
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Arwa AboBakr Ahmed Ibrahim, Resident of Tropical Medicine
- 電話番号:20+01270188007 20+01204935356
- メール:rbkr238@gmail.com
研究連絡先のバックアップ
- 名前:Dr.Ahmad Farooq Alsayed Hasanain, Professor of Tropical Medicine
- 電話番号:20+01020288660
- メール:a.fh@au.egun.ed
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:
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].
Exclusion Criteria:
- 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
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
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 |
|---|---|---|
|
Sarcopenia in metabolic dysfunction-associated steatotic liver disease
時間枠:1 year
|
Predictors of sarcopenia among patients with metabolic associated steatotic liver disease
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sarcopenia in metabolic dysfunction-associated steatotic liver disease
時間枠:1 year
|
Predictors of severe steatosis and fibrosis among patients with metabolic associated steatotic liver disease
|
1 year
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
- Younossi ZM, Golabi P, Paik JM, Henry A, Van Dongen C, Henry L. The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology. 2023 Apr 1;77(4):1335-1347. doi: 10.1097/HEP.0000000000000004. Epub 2023 Jan 3.
- 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.
- 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.
- 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.
- 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(1):16-31. doi: 10.1093/ageing/afy169.
- 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-center study. Metabolism. 2023 Oct;147:155666. doi: 10.1016/j.metabol.2023.155666. Epub 2023 Jul 30.
- Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.
- 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.
- 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.
- Deng C, Ou Q, Ou X, Pan D. Association between non-alcoholic fatty liver disease and risk of sarcopenia: a systematic review and meta-analysis. BMJ Open. 2024 May 6;14(5):e078933. doi: 10.1136/bmjopen-2023-078933.
- Dennison EM, Sayer AA, Cooper C. Epidemiology of sarcopenia and insight into possible therapeutic targets. Nat Rev Rheumatol. 2017 Jun;13(6):340-347. doi: 10.1038/nrrheum.2017.60. Epub 2017 May 4.
- Dirks ML, Wall BT, van de Valk B, Holloway TM, Holloway GP, Chabowski A, Goossens GH, van Loon LJ. One Week of Bed Rest Leads to Substantial Muscle Atrophy and Induces Whole-Body Insulin Resistance in the Absence of Skeletal Muscle Lipid Accumulation. Diabetes. 2016 Oct;65(10):2862-75. doi: 10.2337/db15-1661. Epub 2016 Jun 29.
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- Sarcopenia in MASLD patient
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。