Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

N/ANot Yet RecruitingNCT07598916

Assiut University120 enrolled

Overview

\- 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

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Sarcopenia Among Patients With Metabolic Dysfunction-associated Steatotic Liver Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 \[8\]: 1. BMI ≥ 25 kg/m2 or waist circumference \> 94 cm in men, \> 80 cm in women 2. 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 3. Blood pressure ≥ 130/85 mmHg or specific drug treatment 4. Plasma triglycerides ≥ 150 mg/dL (≥ 1.70 mmol/L) or specific drug treatment 5. 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: 1. Age less than 18 years old or more than 65 years old 2. Pregnant patients 3. Chronic hepatitis C virus and/or hepatitis B virus infection 4. Any alcohol consumption 5. Autoimmune hepatitis 6. Hepatic and/or extrahepatic neoplastic disorders 7. Medication and/or substance use which may lead to hepatic steatosis and/or injury 8. Eating disorders 9. Comorbidities such as neuromuscular, pulmonary, and renal disorders 10. Use of anabolic steroids

Outcomes

Primary Outcomes

Sarcopenia in metabolic dysfunction-associated steatotic liver disease

Predictors of sarcopenia among patients with metabolic associated steatotic liver disease

Time frame: 1 year

Secondary Outcomes

Sarcopenia in metabolic dysfunction-associated steatotic liver disease

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

Time frame: 1 year

Central 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

Data from ClinicalTrials.gov

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