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NCT Number: NCT06908122

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

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.

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Key information

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

laboratory biomarkers in the diagnosis of NAFLD disease

Diagnostic Test

All included patients will be assessed as follows:

  • Questionnaire: different questionnaire variables extrapolated from study published by Xin Li, 2024, Bao et al., 2024 (8), (9).The questionnaire will be divided into six parts: First section includes demographic characteristics of patients as (name , age, gender, occupation, educational level and special habits) The second section includes chronic diseases-related questions and drug administration as if a patient were diagnosed with chronic disease, on treatment and drugs used.

The third section for assessment of dietary lifestyle includes:

nutrition adherence to Mediterranean will be assessed by a validated 17-item MedDiet adherence questionnaire, which all participants will answer. A score will be given for each met objective: 1 (compliance) or 0 (non-compliance).

The counseling session will be about the Mediterranean diet program, and a brochure will be given to each patient.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2025
Registry last updated
Apr 3, 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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