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

Assiut University

Status: Not yet enrolling

Conditions: MAFLD

Study type: Observational

Funder types: Other

Identifiers

NCT06923215

Glucose Disposal Rate in MAFLD

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

30 participants in 1 patient group

Adults with suspected/confirmed metabolic syndrome

Description:

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.