Genetic and Metabolism of Post-prandial HDL Particles (NCT03109067) | Clinical Trial Compass
CompletedNot Applicable
Genetic and Metabolism of Post-prandial HDL Particles
France100 participantsStarted 2011-09-21
Plain-language summary
Reverse cholesterol transport (RCT) pathway explains the anti-atherosclerosis role of HDL. Post prandial hypertriglyceridemia is highly predictive of atherosclerosis. TaqIB polymorphism in CETP gene plays a role on HDL particles, and might give a link between TaqIB polymorphism and the cardioprotective efficiency of HDL particles. Our main objective was to compare post-prandial HDL particles between patients having B2 allele carriers (genotype AA) to B1 allele carriers (genotype GG), and their ability to mediate cellular cholesterol efflux, via SR-BI Scavenger Receptor class B type I (SR-BI) , ABCG1 and ABCA1 pathways.
Who can participate
Age range
18 Years – 60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Affiliation to a national social security scheme
. Age between 18 and 60 years old
. Male subjects
. Participants harboring either a B2 (genotype AA) allele or a B1 (genotype GG) in TaqIB polymorphism of CETP gene
. Fasted plasmatic triglyceridemia \< 300 mg/dL
. Free prior and informed written consent given by the participant
Exclusion criteria
. Participants with an history of symptomatic cardio-vascular disease (infarct, angina pectoris, acute coronary syndrome, cardiac surgery, endoluminal coronal intervention, stroke, symptomatic peripheral artery disease) within 6 months prior to inclusion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of post-prandial HDL particles
Timeframe: before the meal (time = 0 hour) vs 2 hours after
Trial details
NCT IDNCT03109067
SponsorInstitut National de la Santé Et de la Recherche Médicale, France
. Participants having other lipid-lowering agents than statin (fibrate, niacin, ezetimibe)
. Participants having a treatment (either systemic or local) which might interfere with the evaluation of study parameters.
. Excessive alcohol consumption, or any drug addiction. An excessive alcohol consumption is superior to 21 time 30 mL of alcohol or 120 mL of wine or 355 mL of beer.
. Regular smoker or smoking cessation within the last year
. Significant abnormality on the full blood count or plasmatic and urinary biochemistry analysis.
. Chronic or acute disease either life threatening or able to modify study results, including among others :