Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

NCT07598916 | Not Yet Recruiting

• 1 other identifier: Sarcopenia in MASLD patient
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

\- 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

Conditions

Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

Keywords

sarcopenia,MASLD

Outcome Measures

Primary Outcomes (1)

• Sarcopenia in metabolic dysfunction-associated steatotic liver disease

  Predictors of sarcopenia among patients with metabolic associated steatotic liver disease

  1 year

Secondary Outcomes (1)

• Sarcopenia in metabolic dysfunction-associated steatotic liver disease

  1 year

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD) attending the Department of Tropical Medicine \& Gastroenterology at Al-Rajhy Liver Hospital, Assiut University, during the study period.

You may qualify if:

• 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) \[9\].

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• 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.

  PMID: 32033882 BACKGROUND

• 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.

  PMID: 30312372 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 37527759 BACKGROUND

• 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.

  PMID: 37364790 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 38719326 BACKGROUND

• 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.

  PMID: 28469267 BACKGROUND

• 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.

  PMID: 27358494 BACKGROUND

• 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.

  PMID: 31171417 BACKGROUND

• 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.

  PMID: 36626630 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Arwa AboBakr Ahmed Ibrahim, Resident of Tropical Medicine

CONTACT

20+01204935356; rbkr238@gmail.com

Dr.Ahmad Farooq Alsayed Hasanain, Professor of Tropical Medicine

CONTACT

20+01020288660; a.fh@au.egun.ed

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05