Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05486429
Study type Observational
Source Sohag University
Contact Nashwa k Refaie, resident
Phone 201008678735
Email nashwakhalaf@med.sohag.edu.eg
Status Recruiting
Phase
Start date July 20, 2022
Completion date January 20, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05480696 - Soluble Fibre Supplementation in NAFLD Phase 1
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04671186 - Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan N/A
Recruiting NCT05979779 - Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis Phase 2
Recruiting NCT05462353 - Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH Phase 2
Completed NCT05006885 - ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD) Phase 1
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Recruiting NCT04365855 - The Olmsted NAFLD Epidemiology Study (TONES) N/A
Recruiting NCT05618626 - Prevention of NAFLD and CVD Through Lifestyle Intervention N/A
Completed NCT03256526 - 6-week Safety and PD Study in Adults With NAFLD Phase 2
Enrolling by invitation NCT06152991 - Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy Phase 3
Completed NCT03681457 - Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects Phase 1
Completed NCT06244550 - Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors N/A
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Completed NCT03060694 - Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
Completed NCT02526732 - Hepatic Inflammation and Physical Performance in Patients With NASH N/A
Recruiting NCT01988441 - The Influence of Autophagy on Fatty Liver
Recruiting NCT01680003 - Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease Phase 2
Completed NCT01712711 - Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease Phase 2
Recruiting NCT00941642 - Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease Phase 4