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Metabolic Syndrome (MetS)NCT07780253

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

An observational study of Metabolic Syndrome (MetS), run by Assiut University.

Not yet recruiting

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

Official record
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Trial summary

Metabolic syndrome is a major global health burden characterized by a clustering of metabolic abnormalities including central obesity, hypertension, dyslipidaemia, and impaired glucose metabolism. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metabolic Syndrome (MetS)
How many people
96 participants
Where
No sites listed yet
Study dates
Oct 2026to Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with metabolic syndrome

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Malignancy.
  • Pregnancy.
  • Active infection or inflammatory disease

About this study

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].

Read more

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.

Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07780253
Study groupRoleWhat they receive
study groupPatients with metabolic syndrome

What is being measured

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

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

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

    Measured: baseline

Timeline

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

  1. First posted21 Aug 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 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
Case only
Time perspective
Cross-sectional
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07780253
Sponsor's protocol ID
Creatinine-Body Weight Ratio
Status last verified
Aug 2026
First submitted
19 Aug 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Metabolic Syndrome (MetS), 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 11 inclusion and 9 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 21 Aug 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

creatinine-to-body weight ratio in patients with metabolic syndrome (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Aug 2026.

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