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Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver DiseaseNCT07598916

Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

An observational study of Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver Disease, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
How many people
120 participants
Where
No sites listed yet
Study dates
Jun 2026to Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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].

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Arwa AboBakr Ahmed Ibrahim, Resident of Tropical Medicine contact

20+01204935356 ext. 20+01270188007

rbkr238@gmail.com

Dr.Ahmad Farooq Alsayed Hasanain, Professor of Tropical Medicine contact

20+01020288660

a.fh@au.egun.ed

About this study

  • 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
Read the detailed description

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.

Keywords
sarcopenia,MASLD
Medical subject headings
Sarcopenia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sarcopenia in metabolic dysfunction-associated steatotic liver disease

    Predictors of sarcopenia among patients with metabolic associated steatotic liver disease

    Measured: 1 year

Secondary outcomes (1)
  1. Sarcopenia in metabolic dysfunction-associated steatotic liver disease

    Predictors of severe steatosis and fibrosis among patients with metabolic associated steatotic liver disease

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07598916
Sponsor's protocol ID
Sarcopenia in MASLD patient
Status last verified
May 2026
First submitted
14 May 2026
Last updated
20 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 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(1):16-31. doi: 10.1093/ageing/afy169.

    PubMed 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.

    PubMed 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.

    PubMed 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-center study. Metabolism. 2023 Oct;147:155666. doi: 10.1016/j.metabol.2023.155666. Epub 2023 Jul 30.

    PubMed 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, 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.

    PubMed 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.

    PubMed 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.

    PubMed 39214253
  • 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.

    PubMed 38719326
  • 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.

    PubMed 28469267
  • 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.

    PubMed 27358494
  • 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.

    PubMed 31171417
  • 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.

    PubMed 36626630

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver Disease, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arwa AboBakr Ahmed Ibrahim, Resident of Tropical Medicine (20+01204935356 ext. 20+01270188007, rbkr238@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sarcopenia in metabolic dysfunction-associated steatotic liver disease (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07598916, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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