NCT06908122

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	laboratory biomarkers in the diagnosis of NAFLD disease	All included patients will be assessed as follows: 1\. 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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-04-03
• Last updated: 2025-04-03