Assessment Of Lipid Profile In Cirrhotic Patients

Sponsor
Sohag University (Other)
Overall Status
Completed
CT.gov ID
NCT04788173
Collaborator
(none)
100
1
6
16.5

Study Details

Study Description

Brief Summary

Cirrhosis is defined anatomically as a diffuse process with fibrosis and nodule formation. It is the result of the fibrogenesis that occurs with chronic liver injury.

Lipoproteins are complexes of lipid and proteins that are essential for transport of soluble vitamins Liver cells play a serious task in the regulation of lipid metabolism. The principal location for lipoprotein and cholesterol synthesis is in the liver.

In healthy individuals, a compound equilibrium is preserved between utilization, biosynthesis, and transfer of lipid fractions.

Many diseases that affect the parenchyma can lead to changes in the structure of lipoproteins and transport throughout the blood.

Nevertheless, in cirrhotic patients, the metabolism of lipid is changed such that glycogen stores are significantly diminished, contributing to malnutrition and biolysis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Cirrhosis is defined anatomically as a diffuse process with fibrosis and nodule formation. It is the result of the fibrogenesis that occurs with chronic liver injury.

    Lipoproteins are complexes of lipid and proteins that are essential for transport of soluble vitamins Liver cells play a serious task in the regulation of lipid metabolism. The principal location for lipoprotein and cholesterol synthesis is in the liver.

    In healthy individuals, a compound equilibrium is preserved between utilization, biosynthesis, and transfer of lipid fractions.

    Many diseases that affect the parenchyma can lead to changes in the structure of lipoproteins and transport throughout the blood.

    Nevertheless, in cirrhotic patients, the metabolism of lipid is changed such that glycogen stores are significantly diminished, contributing to malnutrition and biolysis.

    The preceding studies have reported that cirrhotic patients have abnormal metabolism of lipids, especially reduction in cholesterol level and hypobetalipoproteinemia.

    These alterations develop together with the progression of liver disease and may be considered as a prognostic markers for liver decompensation.

    The maneuvers concerned with the decline of lipid particles in patients with cirrhosis are compound and need multiple researches for complete understanding.

    Protein microsomal triglyceride (TG) transfer protein -+ MTP], enzymatic (acylCoA:

    cholesterol acyltransferase), and apoprotein (Apo AI) reduction are considered to be linked to these changes.

    Owing to the wide occurrence of liver disease in Egypt, we made this study to assess lipid profile in cirrhotic patients and to evaluate its relation to the degree of cirrhosis.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Assessment Of Lipid Profile In Cirrhotic Patients And Its Relation To The Disease Severity.
    Actual Study Start Date :
    Mar 1, 2021
    Actual Primary Completion Date :
    Sep 1, 2021
    Actual Study Completion Date :
    Sep 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of the lipid profile in cirrhotic patients and compare its levels with normal persons. [15 weeks from start point.]

      Via measurement the levels of triglyceride (TG), total cholesterol,very low-density lipoprotein, low density lipoprotien (LDH), and high-density lipoprotien (HDL) in cirrhotic patients and compare with the control.

    Secondary Outcome Measures

    1. Measurement the degree of liver cirrhosis severity and its relationship to lipid profile levels. [15 weeks from start point]

      Via detecting degree of cirrhosis (according to Child score ) and its relation to the degree of lipid profile.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Cirrhotic patients .
    Exclusion Criteria:
    • 1-Patients with diabetes mellitus,malignancy,uremia. 2-Patients with history of drugs for dyslipidemia. 3- Patients presented with hepatocellular carcinoma 4- Wilsons disease. 5-Rheumatoid arthritis. 6- Systemic lupus.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Sohag Egypt 093

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    manal mostafa kamel, Resident in Tropical Medicine and Gastroenterology Department, Sohag University
    ClinicalTrials.gov Identifier:
    NCT04788173
    Other Study ID Numbers:
    • Soh-Med-21-02-15
    First Posted:
    Mar 9, 2021
    Last Update Posted:
    May 19, 2022
    Last Verified:
    Feb 1, 2021
    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
    Keywords provided by manal mostafa kamel, Resident in Tropical Medicine and Gastroenterology Department, Sohag University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 19, 2022