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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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. All participants undergo:
Clinical/laboratory assessment: Anthropometrics, blood pressure, fasting glucose, HbA1c, lipid profile, liver enzymes, platelet count.
eGDR calculation: Formula incorporating waist circumference, hypertension status, and HbA1c.
FibroScan® evaluation: CAP for steatosis grading (S0-S3) and LSM for fibrosis staging (F0-F4).
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Adults with suspected/confirmed metabolic syndrome
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Glucose Disposal Rate in MAFLD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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