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临床试验/NCT07598916
NCT07598916尚未招募不适用

Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

Assiut University0 个研究点目标入组 120 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120

研究概览

简要总结

- 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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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].

排除标准

  • 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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arwa AboBakr Ahmed Ibrahim

Resident physician

Assiut University

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