Non-Alcoholic Fatty Liver DiseaseNCT05486429
Evaluation of Lipid Profile in Different Grades of Non-alcoholic Fatty Liver Disease Diagnosed by Ultrasound
An observational study of Non-Alcoholic Fatty Liver Disease, run by Sohag University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Abdominal ultrasound and lipid profile
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2022to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: The study will include all adult patients with non - alcoholic fatty liver disease will attend to outpatient clinic of Tropical Medicine Department, Sohag University Hospital.
Who may be able to join
- Adult patients who have non - alcoholic fatty liver by ultrasonography (18-65 years old).
Who cannot join
- HCV, HBV patients.
- Alcoholic patients
- Patients under treatment with lipid lowering drugs.
- Patients under treatment with steatogenic drugs.
- Patients taking hepatotoxic drugs.
Trial locations and contacts
1 site in 1 country.
Khairy H Morsy, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R Elshrif, professor
About this study
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].
Read more
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Abdominal ultrasound and lipid profile
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasound and lipid profileCombination product
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
serum total cholesterol, triglyceride, HDL, LDL, VLDL
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start20 Jul 2022
- Primary completion20 Jan 2023 (estimated)
- Study completion20 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nashwa Khalaf Refaie, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486429
- Sponsor's protocol ID
- Soh-med-22-07-18
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31629366Chalasani 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.
PubMed 28714183Friedman 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.
PubMed 29967350Peng 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.
PubMed 28262209
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lipid Profile in Different Grades of Non-alcoholic Fatty Liver Disease Diagnosed by Ultrasound
- ClinicalTrials.gov ID
- NCT05486429
- Acronym / sponsor ID
- Soh-med-22-07-18
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Jan 2023 (estimated)
- Study completion
- 20 Jan 2023 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will include all adult patients with non - alcoholic fatty liver disease will attend to outpatient clinic of Tropical Medicine Department, Sohag University Hospital.
Key inclusion criteria (1 listed)
- Adult patients who have non - alcoholic fatty liver by ultrasonography (18-65 years old).
Key exclusion criteria (5 listed)
- HCV, HBV patients.
- Alcoholic patients
- Patients under treatment with lipid lowering drugs.
- Patients under treatment with steatogenic drugs.
- Patients taking hepatotoxic drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal ultrasound and lipid profileAll 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. | Combination product | – |
Primary outcome
Lipid profile
Time frame: 6 months
serum total cholesterol, triglyceride, HDL, LDL, VLDL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Background: PubMed 31629366Marjot 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.
- Background: PubMed 28714183Chalasani 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.
- Background: PubMed 29967350Friedman 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.
- Background: PubMed 28262209Peng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khairy H Morsy, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nashwa k Refaie, resident (201008678735, nashwakhalaf@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486429, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.