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

NCT06923215 | Not Yet Recruiting

• 1 other identifier: Glucose Disposal Rate in MAFLD
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

MAFLD

Keywords

MAFLD; eGDR; Fibroscan

Outcome Measures

Primary Outcomes (1)

• eGDR will demonstrate high accuracy for MAFLD detection

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

  3 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at the tropical medicine and gastroenterology in Assuit university.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share