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

NCT ID: NCT05486429

Last Updated: 2022-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-20

Study Completion Date

2023-01-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Abdominal ultrasound and lipid profile

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Nashwa Khalaf Refaie

Resident at Tropical Medicine and Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nashwa k Refaie, resident

Role: CONTACT

201008678735

Khairy H Morsy, professor

Role: CONTACT

201143292343

Facility Contacts

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Osama R Elshrif, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31629366 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28714183 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29967350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28262209 (View on PubMed)

Other Identifiers

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Soh-med-22-07-18

Identifier Type: -

Identifier Source: org_study_id

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