Laboratory biomarkers in the diagnosis of NAFLD disease in Non-alcoholic Fatty Liver Disease - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Non-alcoholic Fatty Liver Disease

Intervention / Treatment

Diagnostic test: laboratory biomarkers in the diagnosis of NAFLD disease

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 Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed as having NAFLD attend outpatient clinics characterized by an age over 18 years.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)