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

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06923215

Enrollment

Registered

2025-04-11

Start date

2025-07-30

Completion date

2026-12-30

Last updated

2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MAFLD

Keywords

MAFLD, eGDR, Fibroscan

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
eGDR will demonstrate high accuracy for MAFLD detection	3 months	eGDR will demonstrate ≥0.75 AUC for MAFLD detection and eGDR will show superior specificity compared to FLI/FIB-4.

Outcome results