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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05486429
Collaborator
(none)
100
1
6
16.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Abdominal ultrasound and lipid profile

Detailed Description

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 [3]. NAFLD is the most common liver disorder worldwide and is present in approximately 25%of the world's population.

People with NAFLD often have no symptoms and NAFLD is often only detectable during routine blood tests or unrelated abdominal imaging or liver biopsy.in some cases NAFLD can cause symptoms such as fatigue, malaise and dull right upper quadrant abdominal discomfort [5]. 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.

Liver biopsy is a sensitive method for diagnosis of NAFLD. However, liver biopsy is painful and invasive procedure with rare, but potentially life-threatening complications like bleeding and is prone to sampling error.

Circulating serum biomarkers of liver fibrosis can give moderate estimates in the diagnosis of liver fibrosis and cirrhosis. The ratio of AST to platelets known as AST /Platelets ratio index (APRI Score) and Fibrotest are recommended as the preferred non invasive tests for cirrhosis by the Asian -Pacific Association for Study of the Liver (APASL).Several other scores such as FIB -4 score and NAFLD fibrosis score can also reflect the burden of fibrosis in the liver.

Dyslipidemia: hypertriglyceridemia, low HDL-C level and high LDL-C level is the most frequent type of lipid abnormality in NAFLD. Previous studies demonstrated that decreased HDL-C levels were associated with occurrence of NAFLD.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Evaluation of Lipid Profile in Different Grades of Non-alcoholic Fatty Liver Disease Diagnosed by Ultrasound
Actual Study Start Date :
Jul 20, 2022
Anticipated Primary Completion Date :
Jan 20, 2023
Anticipated Study Completion Date :
Jan 20, 2023

Outcome Measures

Primary Outcome Measures

  1. Lipid profile [6 months]

    serum total cholesterol, triglyceride, HDL, LDL, VLDL

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Adult patients who have non - alcoholic fatty liver by ultrasonography (18-65 years old).
Exclusion Criteria:
  • HCV, HBV patients.

  • Alcoholic patients

  • Patients under treatment with lipid lowering drugs.

  • Patients under treatment with steatogenic drugs.

  • Patients taking hepatotoxic drugs.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nashwa Khalaf Refaie, Resident at Tropical Medicine and Gastroenterology, Sohag University
ClinicalTrials.gov Identifier:
NCT05486429
Other Study ID Numbers:
  • Soh-med-22-07-18
First Posted:
Aug 3, 2022
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022