About this trial
A 12-month prospective observational cohort study assessing eGDR's utility in diagnosing MAFLD (via FibroScan® CAP ≥248 dB/m) and correlating it with steatosis/fibrosis severity. Secondary aims compare eGDR to FLI/FIB-4 scores and identify optimal diagnostic cut-offs
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years.
Central obesity (waist circumference ≥94 cm [men]/≥80 cm [women]) plus ≥2 of: Triglycerides ≥150 mg/dL.
Disqualifiers
Other liver diseases (viral/autoimmune hepatitis).
Trial population
Adults (18-65 years) with suspected/confirmed metabolic syndrome (IDF criteria) attending a metabolic clinic in Egypt over 12 months. Exclusions include other liver diseases, high alcohol intake, pregnancy, or advanced cirrhosis. All participants undergo: Clinical/laboratory assessment: Anthropometrics, blood pressure, fasting glucose, HbA1c, lipid profile, liver enzymes, platelet count. eGDR calculation: Formula incorporating waist circumference, hypertension status, and HbA1c. FibroScan® evaluation: CAP for steatosis grading (S0-S3) and LSM for fibrosis staging (F0-F4).
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
eGDR will demonstrate high accuracy for MAFLD detection
eGDR will demonstrate ≥0.75 AUC for MAFLD detection and eGDR will show superior specificity compared to FLI/FIB-4.
Locations
Sponsors and contacts
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