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

NCT06908122 | Not Yet Recruiting

• 1 other identifier: FAM.AssiutU
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

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.

  different laboratory ratio will be calculated to assess validity of different laboratory markers in diagnosis of NAFLD

  1 year

Secondary Outcomes (1)

• dietary life style and conduct of Mediterranean diet programme counseling for NAFLD patients attending Assiut university hospitals

  one year

Interventions

laboratory biomarkers in the diagnosis of NAFLD disease DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 36517003 BACKGROUND

• 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.

  PMID: 36577427 BACKGROUND

• 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.

  PMID: 35956364 BACKGROUND

• 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.

  PMID: 35357066 BACKGROUND

• 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.

  PMID: 35136128 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 3, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share