Validity of Laboratory Biomarkers in Diagnosis of Nonalcoholic Fatty Liver Disease (NAFLD) and It's Consequences

Not yet recruiting

• Conditions: Non-alcoholic Fatty Liver Disease

• Registration Number: NCT06908122
• Lead Sponsor: Assiut University

Brief Summary

The validity of laboratory biomarkers in the diagnosis of NAFLD is still not established, and adherence to a healthy dietary lifestyle for those patients in our community is not well studied.

Detailed Description

Non-alcoholic fatty liver disease (NAFLD) is characterized by excessive hepatic fat accumulation, associated with insulin resistance, and defined as the histological presence of steatosis in \>5% hepatocytes.

NAFLD is an umbrella terminology incorporating a spectrum of liver diseases ranging from simple steatosis (nonalcoholic fatty liver), steatohepatitis (nonalcoholic steatohepatitis, NASH), and cirrhosis. NAFLD is also the leading cause of liver cirrhosis, hepatocellular carcinoma, and death.

Early diagnosis and assessment of NAFLD and liver fibrosis are essential for monitoring disease progression and selecting the best treatment options for affected individuals.

Given that liver biopsy had considerable disadvantages, there was a dire need for genuine noninvasive methods for NAFLD detection and risk assessment. The serum markers and other indicators is valuable for screening diseases due to their convenience, low cost, and accuracy of diagnosis Unhealthy dietary composition is an important factor in the progression of non- alcoholic fatty liver disease. Many studies surround the benefits of a Mediterranean diet in conditions such as metabolic syndrome, T2DM, and cardiovascular disease; such conditions often coexist and have a pathophysiological link with NAFLD.

The Mediterranean diet (MeD) is defined as a plant-based diet characterized by a high intake of fruits and vegetables, legumes, whole grains, and a high ratio of monounsaturated fatty acids (MUFA), which is associated with a lower risk of many chronic diseases

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study Start: 2025-04-01
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All adult patients attending outpatient clinics characterized by an age over 18 years.
• Patients diagnosed as NAFLD.

Exclusion Criteria

• Patients younger than 18 years old.
• Patients diagnosed with viral hepatitis to avoid other causes of liver fibrosis. .
• Patients with alcoholic fatty liver (more than three standard drinks per day for men or more than two standard drinks per day for women).
• Patients receiving treatment with drugs known to promote liver steatosis (for example, tamoxifen, amiodarone, estrogen, or corticosteroids).
• Patients with malignant tumors or other severe organ dysfunction diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validity of lab biomarkers in the diagnosis of nonalcoholic fatty liver disease (NAFLD) and it's consequences in comparison with abdominal ultrasound and fibroscan.	1 year	different laboratory ratio will be calculated to assess validity of different laboratory markers in diagnosis of NAFLD

Secondary Outcome Measures

Name	Time	Method
dietary life style and conduct of Mediterranean diet programme counseling for NAFLD patients attending Assiut university hospitals	one year	-nutrition adherence to Mediterranean will be assessed by a validated 17-item MedDiet adherence questionnaire