RE and Probiotics in MAFLD/NAFLD
NCT06563921
Digestive System Diseases, Fatty Liver
View Trial DetailsNCT Number: NCT06923215
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
Trial opening soon.
Get NotifiedPrimary 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Alcohol intake >20 g/day (men) or >10 g/day (women).
Pregnancy, malignancy, advanced cirrhosis.
Medications affecting metabolism (e.g., steroids)
Time frame: 3 months
eGDR will demonstrate ≥0.75 AUC for MAFLD detection and eGDR will show superior specificity compared to FLI/FIB-4.
Assiut University
Other
The Role of Estimated Glucose Disposal Rate as a Metric for Detection of Metabolic Associated Fatty Liver Disease and Its Severity in Patients With Metabolic Syndrome.
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View the official ClinicalTrials.gov record (opens in a new tab)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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