MEPHISTO (Macrophage Phenotype In Metabolic Syndrome With Iron Overload) (NCT02066012) | Clinical Trial Compass
UnknownNot Applicable
MEPHISTO (Macrophage Phenotype In Metabolic Syndrome With Iron Overload)
France60 participantsStarted 2014-02
Plain-language summary
Dysmetabolic iron overload syndrome (DIOS), is a frequent hepatic iron overload associated with metabolic syndrome. We hypothesize that this mild iron overload can induce a increased macrophagic polarization towards inflammatory types, thereby contributing to cardiovascular risk. Our main objective is to highlight the influence of iron overload on polarization capacity of monocytes into alternative macrophages (called M2). We therefore compare phenotypic markers of monocytes/macrophages between subjects with DIOS, metabolic syndrome without iron overload and lean subjects.
Who can participate
Age range
18 Years
Sex
ALL
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:
* • 18 years old and over
* written consent
* for groups M and HSD at least one criteria of the metabolic syndrome definition according to the International Diabetes Federation
* for group M only hepatic iron overload mesured by IRM (above 50 µmol/g) hyperferritnemia between 450 and 1500 µg/l
* for group T only BMI \< 25 kg/m² Waist size \< 80 cm for women and \<94 cm for men
Exclusion Criteria:
* persons under guardianship
* pregnancy
* active smoking
* current inflammatory or cancerous disease
* hereditary hemochromatosis
* use of anti-inflammatory, immunosuppressive or hypoglycaemic drugs
* hemolysis
* alcool consumption above 14 doses for women and 21 doses for men per week
* history of therapeutic phlebotomy
* inflammatory syndrome with CRP above 15 mg/l
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
Expression (RNA) of macrophagic polarization markers