Evaluation of Lipid Profile in Different Grades of Non-alcoholic Fatty Liver Disease Diagnosed by Ultrasound

NCT05486429 | Unknown

• 1 other identifier: Soh-med-22-07-18
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Liver cells play a major role in the regulation of lipid metabolism. They are the principal location for lipoprotein and cholesterol synthesis. In healthy individuals an equilibrium is preserved between utilization, biosynthesis and transfer of lipid fractions. Many diseases that affect the parenchyma of liver can lead to changes in the structure of lipoprotein and transport through blood. Non - alcoholic fatty liver disease (NAFLD) is an abnormal accumulation of fat in the liver in the absence of secondary causes of fatty liver, such as significant alcohol use, viral hepatitis or medications that induce fatty liver. NAFLD is the most common liver disorder worldwide and is present in approximately 25%of the world's population \[3\]. People with NAFLD often have no symptoms and NAFLD is often only detectable during routine blood tests or unrelated abdominal imaging or liver biopsy \[4\].in some cases NAFLD can cause symptoms such as fatigue, malaise and dull right upper quadrant abdominal discomfort. Non - alcoholic steatohepatitis can severely impair liver functions leading to cirrhosis, liver failure and hepatocellular carcinoma. Grading of NAFLD on ultrasound: when the echogenicity is only marginally increases, it is grade 1, when the echogenic liver obscures the echogenic walls of portal vein branches, it is grade 2, and when the echogenic liver obscures the diaphragmatic outlines, it is grade 3 fatty infiltrations.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Lipid profile

  serum total cholesterol, triglyceride, HDL, LDL, VLDL

  6 months

Interventions

Abdominal ultrasound and lipid profile COMBINATION_PRODUCT

All patients will be subjected to: - * Complete history taking with stress on: * Age, sex, comorbid conditions (diabetes, hypertension, ischemic heart disease) * History of intake of lipid lowering drugs. * Thorough clinical examination: General examination, vital sign, height, weight, body mass index. Abdominal examination (hepatomegaly, splenomegaly, ascites) * Laboratory Investigation: 1.Lipid profile (total cholesterol, triglyceride, HDL, LDL, VLDL ( .2Liver function tests (ALT, AST, Albumin, Bilirubin, PT, PC, INR) 3.Complete blood picture. 4.Serology for HBV, HCV. 5.Serum creatinine. 6.Fasting and postprandial blood sugar. * Radiological Investigation: 1.Abdominal ultrasound. * FIB - 4 it combines platelets count, ALI, AST and age. * AST/Platelets ratio index is calculated as (AST/upper limit of normal range) /Platelets count (10\^9/L) ×100.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include all adult patients with non - alcoholic fatty liver disease will attend to outpatient clinic of Tropical Medicine Department, Sohag University Hospital.

You may qualify if:

• Adult patients who have non - alcoholic fatty liver by ultrasonography (18-65 years old).

You may not qualify if:

• HCV, HBV patients.
• Alcoholic patients
• Patients under treatment with lipid lowering drugs.
• Patients under treatment with steatogenic drugs.
• Patients taking hepatotoxic drugs.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• Marjot T, Moolla A, Cobbold JF, Hodson L, Tomlinson JW. Nonalcoholic Fatty Liver Disease in Adults: Current Concepts in Etiology, Outcomes, and Management. Endocr Rev. 2020 Jan 1;41(1):bnz009. doi: 10.1210/endrev/bnz009.

  PMID: 31629366 BACKGROUND

• Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.

  PMID: 28714183 BACKGROUND

• Friedman SL, Neuschwander-Tetri BA, Rinella M, Sanyal AJ. Mechanisms of NAFLD development and therapeutic strategies. Nat Med. 2018 Jul;24(7):908-922. doi: 10.1038/s41591-018-0104-9. Epub 2018 Jul 2.

  PMID: 29967350 BACKGROUND

• Peng K, Mo Z, Tian G. Serum Lipid Abnormalities and Nonalcoholic Fatty Liver Disease in Adult Males. Am J Med Sci. 2017 Mar;353(3):236-241. doi: 10.1016/j.amjms.2017.01.002. Epub 2017 Jan 11.

  PMID: 28262209 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Nashwa k Refaie, resident

CONTACT

201008678735; nashwakhalaf@med.sohag.edu.eg

Khairy H Morsy, professor

CONTACT

201143292343

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Tropical Medicine and Gastroenterology

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: July 20, 2022
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Locations

EG (1)