DyslipidemiaNCT06101771
Assessment of Epicardial Fat Thickness in Children With Familial Dyslipidemia
An observational study of Dyslipidemia, run by Assiut University.
Trial summary
Aim of the study: 1- Detect common types of familial dyslipidemia. 2- Significance and relationship between Epicardial fat thickness and familial dyslipidemia. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- echoCARDIOGRAPHY
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 30 Dec 2025
- 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 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Setting: Tertiary care center ( Assiut University children Hospital) (AUCH) from Sep 2023 to Sep 2025. Normal weight children more than 1 month and till age of 18 years that attend Assiut University children Hospital with Clinical manifestation: 1. Non-symptomatic accidentally discovered dyslipidemia. 2. Steatorrhea. 3. Fatty liver.
Who may be able to join
- Normal weight children more than 1 month and till age of 18 years that attend Assiut University children Hospital with Clinical manifestation:
- Non-symptomatic accidentally discovered dyslipidemia.
- Steatorrhea.
- Fatty liver
Who cannot join
- 1- Patients who had poor echo window : chest deformities, chronic lung disease, pericardial and/or pleural effusion on transthoracic echocardiography, and chronic kidney disease were not included in the study.
- 2. Congenital heart diseases. 3. Children with liver diseases that cause 2ry dyslipidemia. 4. Children with Diabetes that cause 2ry dyslipidemia
Trial locations and contacts
No sites are listed yet.
Faisal-Al Khateeb Al Khateeb ahmed, professor of pediatrics contact
About this study
Official title: Assessment of Epicardial Fat Thickness in Children With Familial Dyslipidemia in Assiut University Children Hospital, Egypt
Aim of the study: 1- Detect common types of familial dyslipidemia. 2- Significance and relationship between Epicardial fat thickness and familial dyslipidemia.
Read the detailed description
Dyslipidemias or dyslipoproteinemias are quantitative changes in total cholesterol concentration, respective fractions, or triglycerides in the plasma. Lipids, such as cholesterol or triglycerides, are absorbed from the intestines and are carried throughout the body via lipoproteins for energy, steroid production, or bile acid formation . Major contributors to these pathways are cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, and high-density lipoprotein (HDL). An imbalance of any of these factors, either from organic or nonorganic causes, can lead to dyslipidemia. Dyslipidemias can result from primary lipoprotein metabolism changes due to different genetic causes (primary dyslipidemias) or as a consequence of exogenous factors or other pathologies (secondary dyslipidemias). Primary dyslipidemia can be due to familial disorders as well. Autosomal dominant mutations cause most cases of familial hypercholesterolemia in LDL receptors, which causes an elevation in LDL-C levels. Other mutations in the cholesterol pathway have been identified but are less common. Several health behaviors can have effects and increase lipid levels. Examples include tobacco use, physical inactivity, nutrition, and obesity. Specifically, nutrition risk factors include the insufficient consumption of fruits, nuts/seeds, vegetables, or high consumption of saturated fats.
The heart and vessels are surrounded by layers of adipose tissue, which is a complex organ composed of adipocytes, stromal cells, macrophages, and a neuronal network, all nourished by a rich microcirculation . The layers of adipose tissue surrounding the heart can be subdivided into intra- and extrapericardial fat. Their thicknesses and volumes can be quantified by echocardiography and CT or magnetic resonance imaging, respectively.
The term extrapericardial fat defines thoracic adipose tissue external to the parietal pericardium. It originates from primitive thoracic mesenchymal cells and thus derives its blood supply from noncoronary sources. Intrapericardial fat is further subdivided into epicardial and pericardial fat. Anatomically, Epicardial and pericardial adipose tissues are clearly different.
Epicardial fat is located between the outer wall of the myocardium and the visceral layer of pericardium. Epicardial adipose tissue (EAT) is a component of visceral adiposity and mediates cardiac function and atherosclerosis via expression of several bioactive molecules.
EAT is a measure of the adipose tissue between the myocardium and visceral pericardium which can be visualized using transthoracic echocardiogram as a non-invasive assessment of EAT. Some studies have used EAT as a marker for metabolic syndrome; however, it does not have standard utility related to other cardiac syndromes. This fat layer buffers the coronary arteries from cardiac contraction and arterial pulse wave while providing the myocardium with necessary substrate through diffusion of free fatty acids. 4 When there is a surplus of energy, free fatty acids are readily converted into triglycerides and stored in epicardial adipocytes, increasing the volume of the epicardial adipose layer and serving as a triglyceride depot for the myocardium to draw from during periods of higher energy needs. Studies in adults suggest that increased EAT results in greater cytokine production in the fat directly surrounding the coronary vessels, including tumor necrosis factor-αas well as several interleukins. These cytokines contribute to atherosclerosis by increasing lipolysis, increasing inflammation, and causing endothelial dysfunction. Endothelial dysfunction coupled with migration of macrophages, basophils, and other cells further exacerbate plaque formation and eventually causes disruption in the structure of the intima and flow within the lumen.8,9Recent studies suggest that increased EAT is predictive of incident CVD in adults with T1D independent of traditional CVD risk factors such as BMI. Although the majority of studies examining EAT have been conducted in the adult population, EAT has been measured in pediatric studies of obesity and metabolic syndrome.
- Conditions
- Dyslipidemia
- Being tested
- echoCARDIOGRAPHY
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echoCARDIOGRAPHYDiagnostic test
Assessment of epicardial fat thickness in children with familial dyslipidemia
| Study group | Role | What they receive |
|---|---|---|
| dyslipidemia | Normal weight children more than 1 month and till age of 18 years that attend Assiut University children Hospital with Clinical manifestation:
1. Non-symptomatic accidentally discovered dyslipidemia.
2. Steatorrhea.
3. Fatty liver. Receives: Diagnostic Test: echoCARDIOGRAPHY |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment epicardial fat thickness in children with familial dyslipidemia
All cases included in the study will be evaluated by:
- - Fasting lipid profile: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Triglycerides (TG). (18)
- - Transthoracic Echocardiography.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start20 Dec 2023 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Mamdouh Wahib Tadros, Assiut University
- Investigators
- Amr Mohamed Kotb, Lecturer of Pediatrics, Study director, Assiut UniversityMohamed Abou Bakr Sobeih, Lecturer of Pediatrics, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101771
- Sponsor's protocol ID
- children with dyslipidemia
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Epicardial Fat Thickness in Children With Familial Dyslipidemia in Assiut University Children Hospital, Egypt
- ClinicalTrials.gov ID
- NCT06101771
- Acronym / sponsor ID
- children with dyslipidemia
- Conditions
- Dyslipidemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Oct 2023 (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.
Aim of the study: 1- Detect common types of familial dyslipidemia. 2- Significance and relationship between Epicardial fat thickness and familial dyslipidemia.
Detailed description
Dyslipidemias or dyslipoproteinemias are quantitative changes in total cholesterol concentration, respective fractions, or triglycerides in the plasma. Lipids, such as cholesterol or triglycerides, are absorbed from the intestines and are carried throughout the body via lipoproteins for energy, steroid production, or bile acid formation . Major contributors to these pathways are cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, and high-density lipoprotein (HDL). An imbalance of any of these factors, either from organic or nonorganic causes, can lead to dyslipidemia. Dyslipidemias can result from primary lipoprotein metabolism changes due to different genetic causes (primary dyslipidemias) or as a consequence of exogenous factors or other pathologies (secondary dyslipidemias). Primary dyslipidemia can be due to familial disorders as well. Autosomal dominant mutations cause most cases of familial hypercholesterolemia in LDL receptors, which causes an elevation in LDL-C levels. Other mutations in the cholesterol pathway have been identified but are less common. Several health behaviors can have effects and increase lipid levels. Examples include tobacco use, physical inactivity, nutrition, and obesity. Specifically, nutrition risk factors include the insufficient consumption of fruits, nuts/seeds, vegetables, or high consumption of saturated fats.
The heart and vessels are surrounded by layers of adipose tissue, which is a complex organ composed of adipocytes, stromal cells, macrophages, and a neuronal network, all nourished by a rich microcirculation . The layers of adipose tissue surrounding the heart can be subdivided into intra- and extrapericardial fat. Their thicknesses and volumes can be quantified by echocardiography and CT or magnetic resonance imaging, respectively.
The term extrapericardial fat defines thoracic adipose tissue external to the parietal pericardium. It originates from primitive thoracic mesenchymal cells and thus derives its blood supply from noncoronary sources. Intrapericardial fat is further subdivided into epicardial and pericardial fat. Anatomically, Epicardial and pericardial adipose tissues are clearly different.
Epicardial fat is located between the outer wall of the myocardium and the visceral layer of pericardium. Epicardial adipose tissue (EAT) is a component of visceral adiposity and mediates cardiac function and atherosclerosis via expression of several bioactive molecules.
EAT is a measure of the adipose tissue between the myocardium and visceral pericardium which can be visualized using transthoracic echocardiogram as a non-invasive assessment of EAT. Some studies have used EAT as a marker for metabolic syndrome; however, it does not have standard utility related to other cardiac syndromes. This fat layer buffers the coronary arteries from cardiac contraction and arterial pulse wave while providing the myocardium with necessary substrate through diffusion of free fatty acids. 4 When there is a surplus of energy, free fatty acids are readily converted into triglycerides and stored in epicardial adipocytes, increasing the volume of the epicardial adipose layer and serving as a triglyceride depot for the myocardium to draw from during periods of higher energy needs. Studies in adults suggest that increased EAT results in greater cytokine production in the fat directly surrounding the coronary vessels, including tumor necrosis factor-αas well as several interleukins. These cytokines contribute to atherosclerosis by increasing lipolysis, increasing inflammation, and causing endothelial dysfunction. Endothelial dysfunction coupled with migration of macrophages, basophils, and other cells further exacerbate plaque formation and eventually causes disruption in the structure of the intima and flow within the lumen.8,9Recent studies suggest that increased EAT is predictive of incident CVD in adults with T1D independent of traditional CVD risk factors such as BMI. Although the majority of studies examining EAT have been conducted in the adult population, EAT has been measured in pediatric studies of obesity and metabolic syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dyslipidemia | – | Diagnostic Test: echoCARDIOGRAPHYNormal weight children more than 1 month and till age of 18 years that attend Assiut University children Hospital with Clinical manifestation: 1. Non-symptomatic accidentally discovered dyslipidemia. 2. Steatorrhea. 3. Fatty liver. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Setting: Tertiary care center ( Assiut University children Hospital) (AUCH) from Sep 2023 to Sep 2025. Normal weight children more than 1 month and till age of 18 years that attend Assiut University children Hospital with Clinical manifestation: 1. Non-symptomatic accidentally discovered dyslipidemia. 2. Steatorrhea. 3. Fatty liver.
Key inclusion criteria (4 listed)
- Normal weight children more than 1 month and till age of 18 years that attend Assiut University children Hospital with Clinical manifestation:
Key exclusion criteria (2 listed)
- 1- Patients who had poor echo window : chest deformities, chronic lung disease, pericardial and/or pleural effusion on transthoracic echocardiography, and chronic kidney disease were not included in the study.
- 2. Congenital heart diseases. 3. Children with liver diseases that cause 2ry dyslipidemia. 4. Children with Diabetes that cause 2ry dyslipidemia
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 |
|---|---|---|
| echoCARDIOGRAPHYAssessment of epicardial fat thickness in children with familial dyslipidemia | Diagnostic test | dyslipidemia |
Primary outcome
assessment epicardial fat thickness in children with familial dyslipidemia
Time frame: baseline
All cases included in the study will be evaluated by: 1. - Fasting lipid profile: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Triglycerides (TG). (18) 2. - Transthoracic Echocardiography.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- 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.
Faisal-Al Khateeb Al Khateeb ahmed, professor of pediatrics contact
Amr Mohamed Kotb, Lecturer of Pediatrics study director
Assiut University
Mohamed Abou Bakr Sobeih, Lecturer of Pediatrics study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia, run by Assiut University.
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 4 inclusion and 2 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 mina mamdoh Tadros, resident doctor (+201286186279, do7a.mmdoh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment epicardial fat thickness in children with familial dyslipidemia (time frame: baseline). 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 26 Oct 2023.