MEPHISTO (Macrophage Phenotype In Metabolic Syndrome With Iron Overload)
MEPHISTO
Impact of Dysmetabolic Iron Overload Syndrome on Polarization Capacity of Macrophages
2 other identifiers
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFebruary 19, 2014
February 1, 2014
6 months
February 14, 2014
February 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Expression (RNA) of macrophagic polarization markers
Expression (RNA) of macrophagic polarization markers (MR, CD200R, F13A1, CD163, AMAC1, TGFβ), among subjects with or without iron overload
at day 1
Secondary Outcomes (1)
characteristics of the subjects
at day 1
Study Arms (3)
group DIOS
group DIOS composed of subjects with dysmetabolic hepatosiderosis
group M
group M composed of subjects with metabolic syndrom without iron overload
group T
group T composed of lean subjects
Interventions
Eligibility Criteria
metabolic syndrome
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc RUIVARD
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 19, 2014
Study Start
February 1, 2014
Primary Completion
August 1, 2014
Study Completion
October 1, 2014
Last Updated
February 19, 2014
Record last verified: 2014-02