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NCT Number: NCT06923215

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

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. eGDR will demonstrate high accuracy for MAFLD detection

    Time frame: 3 months

    eGDR will demonstrate ≥0.75 AUC for MAFLD detection and eGDR will show superior specificity compared to FLI/FIB-4.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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