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NCT Number: NCT07598916

Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

- 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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sarcopenia in metabolic dysfunction-associated steatotic liver disease

    Time frame: 1 year

    Predictors of sarcopenia among patients with metabolic associated steatotic liver disease

Secondary outcomes

  1. Sarcopenia in metabolic dysfunction-associated steatotic liver disease

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Arwa AboBakr Ahmed Ibrahim, Resident of Tropical Medicine

CONTACT

[email protected]

20+01204935356 ext. 20+01270188007

Dr.Ahmad Farooq Alsayed Hasanain, Professor of Tropical Medicine

CONTACT

[email protected]

20+01020288660

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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