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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04788173
Other study ID # Soh-Med-21-02-15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date September 1, 2021

Study information

Verified date February 2021
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Sohag University Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of the lipid profile in cirrhotic patients and compare its levels with normal persons. 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. 15 weeks from start point.
Secondary Measurement the degree of liver cirrhosis severity and its relationship to lipid profile levels. Via detecting degree of cirrhosis (according to Child score ) and its relation to the degree of lipid profile. 15 weeks from start point
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