CirrhosisNCT04788173
Assessment Of Lipid Profile In Cirrhotic Patients
An observational study of Cirrhosis, run by Sohag University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Sep 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with liver cirrhosis. Diagnosis of liver cirrhosis depend on clinical, laboratory, and radiological finding.
Who may be able to join
- Cirrhotic patients .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment Of Lipid Profile In Cirrhotic Patients And Its Relation To The Disease Severity.
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.
Read more
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.
Read the 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.
- Conditions
- Cirrhosis
- Keywords
- cirrhosis, lipid profile
- Medical subject headings
- Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 weeks from start point.
Secondary outcomes (1)
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.
Measured: 15 weeks from start point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, manal mostafa kamel, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788173
- Sponsor's protocol ID
- Soh-Med-21-02-15
- Status last verified
- Feb 2021
- First submitted
- 1 Mar 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Lipid Profile In Cirrhotic Patients And Its Relation To The Disease Severity.
- ClinicalTrials.gov ID
- NCT04788173
- Acronym / sponsor ID
- Soh-Med-21-02-15
- Conditions
- Cirrhosis
- Keywords
- cirrhosis, lipid profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 9 Mar 2021 (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.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis. Diagnosis of liver cirrhosis depend on clinical, laboratory, and radiological finding.
Key inclusion criteria (1 listed)
- Cirrhotic patients .
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of the lipid profile in cirrhotic patients and compare its levels with normal persons.
Time frame: 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.
1 secondary outcome
Measurement the degree of liver cirrhosis severity and its relationship to lipid profile levels.
Time frame: 15 weeks from start point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: Undecided. 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cirrhosis, 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 1 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: finished, as of the sponsor's last update on 19 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the lipid profile in cirrhotic patients and compare its levels with normal persons. (time frame: 15 weeks from start point.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2022.