Clinical trial NCT06908122: Validity of Laboratory Biomarkers in Diagnosis of Nonalcoholic Fatty Liver Disease (NAFLD) and It's Consequences
Official title: Validity of Laboratory Biomarkers in Diagnosis of Nonalcoholic Fatty Liver Disease (NAFLD) and It's Consequences
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as having NAFLD attend outpatient clinics characterized by an age over 18 years.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Validity of lab biomarkers in the diagnosis of nonalcoholic fatty liver disease (NAFLD) and it's consequences in comparison with abdominal ultrasound and fibroscan.
timeFrame: 1 year
Secondary outcomes:
measure: dietary life style and conduct of Mediterranean diet programme counseling for NAFLD patients attending Assiut university hospitals
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
citation: Ko E, Yoon EL, Jun DW. Risk factors in nonalcoholic fatty liver disease. Clin Mol Hepatol. 2023 Feb;29(Suppl):S79-S85. doi: 10.3350/cmh.2022.0398. Epub 2022 Dec 14.
citation: Han SK, Baik SK, Kim MY. Non-alcoholic fatty liver disease: Definition and subtypes. Clin Mol Hepatol. 2023 Feb;29(suppl):S5-S16. doi: 10.3350/cmh.2022.0424. Epub 2022 Dec 28.
citation: Montemayor S, Mascaro CM, Ugarriza L, Casares M, Llompart I, Abete I, Zulet MA, Martinez JA, Tur JA, Bouzas C. Adherence to Mediterranean Diet and NAFLD in Patients with Metabolic Syndrome: The FLIPAN Study. Nutrients. 2022 Aug 3;14(15):3186. doi: 10.3390/nu14153186.
citation: George ES, Reddy A, Nicoll AJ, Ryan MC, Itsiopoulos C, Abbott G, Johnson NA, Sood S, Roberts SK, Tierney AC. Impact of a Mediterranean diet on hepatic and metabolic outcomes in non-alcoholic fatty liver disease: The MEDINA randomised controlled trial. Liver Int. 2022 Jun;42(6):1308-1322. doi: 10.1111/liv.15264. Epub 2022 Apr 26.
citation: Doustmohammadian A, Clark CCT, Maadi M, Motamed N, Sobhrakhshankhah E, Ajdarkosh H, Mansourian MR, Esfandyari S, Hanjani NA, Nikkhoo M, Zamani F. Favorable association between Mediterranean diet (MeD) and DASH with NAFLD among Iranian adults of the Amol Cohort Study (AmolCS). Sci Rep. 2022 Feb 8;12(1):2131. doi: 10.1038/s41598-022-06035-8.