Detect the Significance of Remnant Cholesterol in Detection Severity of MAFLDMAFLDNCT06449092
The Significance of Remnant Cholesterol and Carotid Intima Media Thickness in Patients With MAFLD
An observational study of Detect the Significance of Remnant Cholesterol in Detection Severity of MAFLD, run by Assiut University at 1 site in Egypt.
Trial summary
1. To detect the significance of remenant cholesterol in detection severity of MAFLD 2. To detect the significance of carotid intima-media thickness in MAFLD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Detect the Significance of Remnant Cholesterol in Detection Severity of MAFLD
- What is being tested?
- Lipid profile
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2025to Jan 2026
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The study will include patients presented to Fibroscan clinic, Internal medicine department at Assiut University hospitals within 1 year
Who may be able to join
- The study will include adult patients (≥18 years) presented to fibroscan clinic and diagnosed as MAFLD.
Who cannot join
- Patients Known previous cardiac disease ( cardiovascular disease, heart failure, arrhythmia )
- Patients Known liver cirrhosis
- septic patients
- Patients have malignancy
Trial locations and contacts
1 site in 1 country.
About this study
- To detect the significance of remenant cholesterol in detection severity of MAFLD
- To detect the significance of carotid intima-media thickness in MAFLD
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is fatty infiltration of the liver in the absence of other causes of steatosis, such as alcohol consumption characterized by excessive fat accumulation in liver >5-10% of its weight encompassing a spectrum of increasingly severe clinico-pathological conditions - nonalcoholic fatty liver (NAFL) and nonalcoholic steato-hepatitis (NASH) with or without fibrosis/cirrhosis. Since NAFLD is frequently associated with further metabolic comorbidities such as obesity, type 2 diabetes mellitus, or dyslipidemia, it is generally considered as the hepatic manifestation of the metabolic syndrome A growing body of evidence also indicates that NAFLD is strongly associated with an increased risk of major CVD events and other cardiac complications (ie, cardiomyopathy, cardiac valvular calcification and cardiac arrhythmias), independently of traditional cardiovascular risk factors NAFLD has also been associated with an increase in the carotid intima- media thickness (CIMT), independent of conventional CVD risk factors. CIMT is a marker of early atherosclerosis and has been shown to predict increased risks of myocardial in-farction and stroke Fatty liver index (FLI) has been proposed as an accurate, convenient, and economic surrogate of the severity of NAFLD. Remnant cholesterol refers to the cholesterol content carried by triglyceride-rich lipoproteins, which include non-LDL-C and nonhigh density lipoprotein-cholesterol (HDL-C) A large number of studies have reported that serum remnant cholesterol levels were positively associated with the risk of coronary artery disease NAFLD
, type 2 diabetes , and metabolic syndrome
- Being tested
- Lipid profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid profileDiagnostic test
Also called color doppler
carotid intima media thickness
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect the significance of remnant cholesterol in detection severity of MAFLD
lipid profile in MAFLD patients to detect remnant cholesterol
Measured: From Jan 2025 to Jan 2026
To detect the relationship between carotid intima-media thickness and remnant cholesterol in MAFLD and prediction of cardiovascular effect.
color doppler and echocardiography in MAFLD patients
Measured: From Jan 2025 to Jan 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Detect the Significance of Remnant Cholesterol in Detection Severity of MAFLDStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Khaled Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449092
- Sponsor's protocol ID
- Severity of MAFLD
- Acronym
- MAFLD
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of Remnant Cholesterol and Carotid Intima Media Thickness in Patients With MAFLD
- ClinicalTrials.gov ID
- NCT06449092
- Acronym / sponsor ID
- MAFLD / Severity of MAFLD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 7 Jun 2024 (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.
- To detect the significance of remenant cholesterol in detection severity of MAFLD
- To detect the significance of carotid intima-media thickness in MAFLD
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is fatty infiltration of the liver in the absence of other causes of steatosis, such as alcohol consumption characterized by excessive fat accumulation in liver >5-10% of its weight encompassing a spectrum of increasingly severe clinico-pathological conditions - nonalcoholic fatty liver (NAFL) and nonalcoholic steato-hepatitis (NASH) with or without fibrosis/cirrhosis. Since NAFLD is frequently associated with further metabolic comorbidities such as obesity, type 2 diabetes mellitus, or dyslipidemia, it is generally considered as the hepatic manifestation of the metabolic syndrome A growing body of evidence also indicates that NAFLD is strongly associated with an increased risk of major CVD events and other cardiac complications (ie, cardiomyopathy, cardiac valvular calcification and cardiac arrhythmias), independently of traditional cardiovascular risk factors NAFLD has also been associated with an increase in the carotid intima- media thickness (CIMT), independent of conventional CVD risk factors. CIMT is a marker of early atherosclerosis and has been shown to predict increased risks of myocardial in-farction and stroke Fatty liver index (FLI) has been proposed as an accurate, convenient, and economic surrogate of the severity of NAFLD. Remnant cholesterol refers to the cholesterol content carried by triglyceride-rich lipoproteins, which include non-LDL-C and nonhigh density lipoprotein-cholesterol (HDL-C) A large number of studies have reported that serum remnant cholesterol levels were positively associated with the risk of coronary artery disease NAFLD
, type 2 diabetes , and metabolic syndrome
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will include patients presented to Fibroscan clinic, Internal medicine department at Assiut University hospitals within 1 year
Key inclusion criteria (1 listed)
- The study will include adult patients (≥18 years) presented to fibroscan clinic and diagnosed as MAFLD.
Key exclusion criteria (4 listed)
- Patients Known previous cardiac disease ( cardiovascular disease, heart failure, arrhythmia )
- Patients Known liver cirrhosis
- septic patients
- Patients have malignancy
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 |
|---|---|---|
| Lipid profileAlso: color dopplercarotid intima media thickness | Diagnostic test | – |
Primary outcome
To detect the significance of remnant cholesterol in detection severity of MAFLD
Time frame: From Jan 2025 to Jan 2026
lipid profile in MAFLD patients to detect remnant cholesterol
To detect the relationship between carotid intima-media thickness and remnant cholesterol in MAFLD and prediction of cardiovascular effect.
Time frame: From Jan 2025 to Jan 2026
color doppler and echocardiography in MAFLD patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: Undecided
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.
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 Detect the Significance of Remnant Cholesterol in Detection Severity of MAFLD, run by Assiut 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 4 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 7 Jun 2024. 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 Ahmed Kh Nazier (01005897058, ak0555012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect the significance of remnant cholesterol in detection severity of MAFLD (time frame: From Jan 2025 to Jan 2026). The study lists 2 primary outcomes in all. 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 7 Jun 2024.