Glucose Disposal Rate as a Metric for Detection of Metabolic Associated Fatty Liver

N/ANot Yet RecruitingNCT06923215

Assiut University30 enrolled

Overview

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

Primary Aim Determine eGDR's diagnostic accuracy for MAFLD using FibroScan® (CAP ≥248 dB/m) as the gold standard. Secondary Aims Correlate eGDR with MAFLD severity (steatosis via CAP, fibrosis via liver stiffness measurement \[LSM\]). Compare eGDR's performance to Fatty Liver Index (FLI) and FIB-4 in detecting MAFLD and predicting fibrosis. Identify optimal eGDR cut-offs for MAFLD detection (\<6 mg/kg/min) and advanced fibrosis staging (\<4 mg/kg/min). Evaluate eGDR's reclassification improvement (net reclassification index \>10%) over existing scores.

Study Type

OBSERVATIONAL

Enrollment

Conditions

MAFLD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-65 years. * Suspected/confirmed MS per IDF criteria: * Central obesity (waist circumference ≥94 cm \[men\]/≥80 cm \[women\]) plus ≥2 of: Triglycerides ≥150 mg/dL. HDL \<40 mg/dL (men)/\<50 mg/dL (women). Blood pressure ≥130/85 mmHg or antihypertensive treatment. Fasting glucose ≥100 mg/dL or diabetes diagnosis. Exclusion Criteria: * Other liver diseases (viral/autoimmune hepatitis). Alcohol intake \>20 g/day (men) or \>10 g/day (women). Pregnancy, malignancy, advanced cirrhosis. Medications affecting metabolism (e.g., steroids)

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.

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.