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NCT Number: NCT07780253

Creatinine-Body Weight Ratio as a Predictor of Hepatic Steatosis in Patients With Metabolic Syndrome

Metabolic syndrome is a major global health burden characterized by a clustering of metabolic abnormalities including central obesity, hypertension, dyslipidaemia, and impaired glucose metabolism. Recent modelling data indicated that the worldwide prevalence of metabolic syndrome doubled between 2000 and 2023, reaching approximately 31% among women and 26% among men, with an estimated 1.54 billion adults affected globally [1].

In the Middle East and North Africa region, the prevalence of metabolic syndrome-associated liver disease has been reported to reach nearly 40% in the general population [2].

Hepatic steatosis, now referred to as metabolic dysfunction-associated steatotic liver disease (MASLD) following the 2023 multi-society Delphi consensus statement, encompasses a spectrum of conditions ranging from simple steatosis to steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma [3]. The global prevalence of NAFLD/MASLD has been estimated at approximately 32.4%, with a steadily increasing trend over the past two decades [4].

Given that early identification of hepatic steatosis may prevent progression to advanced liver disease, there is a clinical need for simple, inexpensive, and readily available screening biomarkers [5].

Serum creatinine is traditionally used as a marker of renal function; however, because creatinine is generated as a metabolic end-product of skeletal muscle, its circulating concentration also reflects total body muscle mass. Adjusting serum creatinine for body weight yields the creatinine-to-body weight (Cr/BW) ratio, which has been proposed as a simple surrogate marker of relative muscle mass and sarcopenic obesity [6].

In a landmark longitudinal cohort of 13,728 participants, participants in the lowest Cr/BW quartile demonstrated a significantly higher cumulative incidence of NAFLD compared with the highest quartile, confirming Cr/BW as an independent predictor of fatty liver disease [7].

Reduced skeletal muscle mass and sarcopenia are increasingly recognized as contributors to insulin resistance and metabolic dysfunction, both of which are central to the pathogenesis of MASLD [8]. A bidirectional relationship between the Cr/BW ratio and NAFLD has been demonstrated in a longitudinal study of 9,662 participants followed for four years, suggesting that low muscle mass and hepatic steatosis may reinforce one another [9].

Furthermore, a recent cross-sectional study of 1,492 participants found that the Cr/BW ratio independently predicted the severity of hepatic steatosis as measured by controlled attenuation parameter, with a threshold of 1.01 identifying high-risk individuals [10].

Despite this emerging evidence, published data on the predictive value of the Cr/BW ratio for hepaticsteatosis specifically in patients with metabolic syndrome remain limited. Most existing studies were conducted in East Asian populations and focused on NAFLD without selecting for the metabolic syndrome phenotype. Therefore, this study aims to evaluate the predictive value of the Cr/BW ratio for hepatic steatosis in patients with metabolic syndrome attending Assiut University Hospital.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged ≥18 years. • Patients fulfilling criteria of metabolic syndrome

Metabolic syndrome will be diagnosed according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria. Presence of at least three of the following:

  • Waist circumference:
  • Men>102 cm
  • Women>88 cm
  • Triglycerides ≥150 mg/dL or treatment for hypertriglyceridemia.
  • HDL cholesterol:
  • Men<40 mg/dL
  • Women<50 mg/dL
  • Blood pressure ≥130/85 mmHg or current antihypertensive treatment.
  • Fasting blood glucose ≥100 mg/dL or treatment for diabetes mellitus. • Patients willing to participate and provide informed consent.

Exclusion criteria

  • Chronic liver disease other than MASLD.
  • Viral hepatitis B or C.
  • Significant alcohol intake.
  • Hepatotoxic drug use.
  • Chronic kidney disease stage 4 or 5.
  • Acute kidney injury.
  • Malignancy.
  • Pregnancy.
  • Active infection or inflammatory disease

Treatment and study plan

Primary outcomes

  1. creatinine-to-body weight ratio in patients with metabolic syndrome

    Time frame: baseline

    creatinine-to-body weight ratio in patients with metabolic syndrome

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

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

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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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