Dysmetabolic Iron Overload SyndromeMEPHISTONCT02066012
MEPHISTO (Macrophage Phenotype In Metabolic Syndrome With Iron Overload)
An observational study of Dysmetabolic Iron Overload Syndrome and Metabolic Syndrome X, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysmetabolic Iron Overload Syndrome, Metabolic Syndrome X
- What is being tested?
- dysmetabolic iron overload syndrome
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Oct 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: metabolic syndrome
Who may be able to join
- • 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
Who cannot join
- persons under guardianship
- pregnancy
- active smoking
- current inflammatory or cancerous disease
- hereditary hemochromatosis
- use of anti-inflammatory, immunosuppressive or hypoglycaemic drugs
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-celrmontferrand.fr
About this study
Official title: Impact of Dysmetabolic Iron Overload Syndrome on Polarization Capacity of Macrophages
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.
Read the detailed description
MEPHISTO is a pathophysiological, transverse, case-control, single-center study (university hospital, Clermont-Ferrand, France). No intervention (drug or nutritional) is conducted as part of this study and the participants are not subject to any exclusion period. Our objective is to investigate the effects of iron overload on monocyte/macrophage polarization and its relations with the cardiovascular risk factors.
We study 60 subjects divided into 3 groups of 20 participants :
- group DIOS composed of subjects with dysmetabolic hepatosiderosis
- group M composed of subjects with metabolic syndrom without iron overload
- group T composed of lean subjects DIOS group participants were selected among patients recently diagnosed as DIOS, without any secondary hyperferritinemia and with hepatic iron overload proved by liver MRI.
Recruitement of group DIOS was carried out in the internal medicine service. Subjects of group M and DIOS come from the file of volunteers from the center of clinical investigation (CIC-501, Clermont-Ferrand). Subject of group M to group DIOS are matched by age, gender (+/- 5 kg/m²) and BMI. Subjects of group T to group DIOS are matched by age and gender. As no direct benefit is expected for the participants, they receive a lump sum compensation of 50 euros.
Each participant undergoes only a 1 hour consultation including a clinical examination and blood sample.
We focus on clinical parameters of the metabolic syndrome (waist size, BMI, blood pressure) and on seeking exclusion factors (infection, neoplasia, anti-inflammatory drugs). Due to their potential influence on inflammation and oxidant stress, these factors, as same as smoking were excluded.
Blood sample will be used to perform:
- classical laboratory test (blood count, reticulocytes, ASAT, ALAT, LDH, lipid profile, glycemia, insulinemia, TSH, , vitamin D, ferritin, transferrin saturation, CRP),
- specific dosages (IL-6, TNFalpha, hepcidine) by ELISA,
- monocyte phenotype ( CD14, CD16, CD 163, MR) by FACS (Fluorescence Activated Cell Sorting),
- measurement of the gene expression from monocytes and macrophages after culturing by real-time PCR.
Our main analysis focus on ex vivo polarization of monocytes into alternative macrophages (M2) and phenotypic characterization. Before and after culturing monocytes with (to induce M2 macrophage) or without IL-4 (to induce resident macrophage), we will measure the expression of phenotypic markers of polarization (MR, CD200R, F13A1, CD163, AMAC1, TGFb), inflammatory markers (TNFα , MCP- 1, IL-6) , oxidative stress markers (HO- 1 ), and markers of iron metabolism (ferroportin, ferritin, hepcidin). We use quantitative PCR microfluidic card (TLDA, Taqman Low-Density Array) to measure gene expression of monocytes and type M2 macrophages. This technique allows screening of expression for 24 genes. Different phases are required: RNA extraction (RNeasy kit, Qiagen), the reverse transcription (RT-PCR kit, HighCap cDNA RT kit, Applied Biosystems), amplification (TaqMan Fast Advanced Master Mix, Applied Biosystems), and finally the study of gene expression (MFC TaqMan Array for GeneEx, Format 24, Applied Biosystems). Our main outcome is capacity of polarization in M2 macrophages evidenced by expression of MR, CD200R, F13A1, CD163, AMAC1, TGFb. Evaluating the influence of iron overload on data from the clinical examination, the results of standard biology and monocyte gene expression is our secondary outcome.
- Being tested
- dysmetabolic iron overload syndrome
- Keywords
- Dysmetabolic Iron Overload Syndrome, Metabolic Syndrome X, Iron, Monocyte, Macrophage, Polarization
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dysmetabolic iron overload syndromeOther
| Study group | Role | What they receive |
|---|---|---|
| group DIOS | group DIOS composed of subjects with dysmetabolic hepatosiderosis Receives: Other: dysmetabolic iron overload syndrome | |
| group M | group M composed of subjects with metabolic syndrom without iron overload Receives: Other: dysmetabolic iron overload syndrome | |
| group T | group T composed of lean subjects Receives: Other: dysmetabolic iron overload syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 1
Secondary outcomes (1)
characteristics of the subjects
Statistical relationships between monocyte phenotype and clinical (metabolic abnormalities) or biological (level of iron overload, oxidative stress and insulino-resistance) characteristics of the subjects.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmetabolic Iron Overload SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
- Investigators
- Marc RUIVARD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066012
- Sponsor's protocol ID
- CHU-0180
- Other IDs
- 2013-A01687-38
- Acronym
- MEPHISTO
- Status last verified
- Feb 2014
- First submitted
- 14 Feb 2014
- Last updated
- 19 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dysmetabolic Iron Overload Syndrome on Polarization Capacity of Macrophages
- ClinicalTrials.gov ID
- NCT02066012
- Acronym / sponsor ID
- MEPHISTO / CHU-0180
- Keywords
- Dysmetabolic Iron Overload Syndrome, Metabolic Syndrome X, Iron, Monocyte, Macrophage, Polarization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 19 Feb 2014 (estimated)
- 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.
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.
Detailed description
MEPHISTO is a pathophysiological, transverse, case-control, single-center study (university hospital, Clermont-Ferrand, France). No intervention (drug or nutritional) is conducted as part of this study and the participants are not subject to any exclusion period. Our objective is to investigate the effects of iron overload on monocyte/macrophage polarization and its relations with the cardiovascular risk factors.
We study 60 subjects divided into 3 groups of 20 participants :
- group DIOS composed of subjects with dysmetabolic hepatosiderosis
- group M composed of subjects with metabolic syndrom without iron overload
- group T composed of lean subjects DIOS group participants were selected among patients recently diagnosed as DIOS, without any secondary hyperferritinemia and with hepatic iron overload proved by liver MRI.
Recruitement of group DIOS was carried out in the internal medicine service. Subjects of group M and DIOS come from the file of volunteers from the center of clinical investigation (CIC-501, Clermont-Ferrand). Subject of group M to group DIOS are matched by age, gender (+/- 5 kg/m²) and BMI. Subjects of group T to group DIOS are matched by age and gender. As no direct benefit is expected for the participants, they receive a lump sum compensation of 50 euros.
Each participant undergoes only a 1 hour consultation including a clinical examination and blood sample.
We focus on clinical parameters of the metabolic syndrome (waist size, BMI, blood pressure) and on seeking exclusion factors (infection, neoplasia, anti-inflammatory drugs). Due to their potential influence on inflammation and oxidant stress, these factors, as same as smoking were excluded.
Blood sample will be used to perform:
- classical laboratory test (blood count, reticulocytes, ASAT, ALAT, LDH, lipid profile, glycemia, insulinemia, TSH, , vitamin D, ferritin, transferrin saturation, CRP),
- specific dosages (IL-6, TNFalpha, hepcidine) by ELISA,
- monocyte phenotype ( CD14, CD16, CD 163, MR) by FACS (Fluorescence Activated Cell Sorting),
- measurement of the gene expression from monocytes and macrophages after culturing by real-time PCR.
Our main analysis focus on ex vivo polarization of monocytes into alternative macrophages (M2) and phenotypic characterization. Before and after culturing monocytes with (to induce M2 macrophage) or without IL-4 (to induce resident macrophage), we will measure the expression of phenotypic markers of polarization (MR, CD200R, F13A1, CD163, AMAC1, TGFb), inflammatory markers (TNFα , MCP- 1, IL-6) , oxidative stress markers (HO- 1 ), and markers of iron metabolism (ferroportin, ferritin, hepcidin). We use quantitative PCR microfluidic card (TLDA, Taqman Low-Density Array) to measure gene expression of monocytes and type M2 macrophages. This technique allows screening of expression for 24 genes. Different phases are required: RNA extraction (RNeasy kit, Qiagen), the reverse transcription (RT-PCR kit, HighCap cDNA RT kit, Applied Biosystems), amplification (TaqMan Fast Advanced Master Mix, Applied Biosystems), and finally the study of gene expression (MFC TaqMan Array for GeneEx, Format 24, Applied Biosystems). Our main outcome is capacity of polarization in M2 macrophages evidenced by expression of MR, CD200R, F13A1, CD163, AMAC1, TGFb. Evaluating the influence of iron overload on data from the clinical examination, the results of standard biology and monocyte gene expression is our secondary outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group DIOS | – | Other: dysmetabolic iron overload syndromegroup DIOS composed of subjects with dysmetabolic hepatosiderosis |
| group M | – | Other: dysmetabolic iron overload syndromegroup M composed of subjects with metabolic syndrom without iron overload |
| group T | – | Other: dysmetabolic iron overload syndromegroup T composed of lean subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- metabolic syndrome
Key inclusion criteria (5 listed)
- • 18 years old and over
Key exclusion criteria (10 listed)
- persons under guardianship
- pregnancy
- active smoking
- current inflammatory or cancerous disease
- hereditary hemochromatosis
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 |
|---|---|---|
| dysmetabolic iron overload syndrome | Other | group DIOS, group M, group T |
Primary outcome
Expression (RNA) of macrophagic polarization markers
Time frame: at day 1
Expression (RNA) of macrophagic polarization markers (MR, CD200R, F13A1, CD163, AMAC1, TGFβ), among subjects with or without iron overload
1 secondary outcome
characteristics of the subjects
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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.
Marc RUIVARD principal investigator
University Hospital, Clermont-Ferrand
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 Dysmetabolic Iron Overload Syndrome and Metabolic Syndrome X, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 10 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 19 Feb 2014. 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 France. 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 Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression (RNA) of macrophagic polarization markers (time frame: at day 1). 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 19 Feb 2014.