Impact of Dysmetabolic Iron Overload Syndrome on Polarization Capacity of Macrophages
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Expression (RNA) of macrophagic polarization markers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• 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
排除标准
- •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
结局指标
主要结局
Expression (RNA) of macrophagic polarization markers
时间窗: at day 1
Expression (RNA) of macrophagic polarization markers (MR, CD200R, F13A1, CD163, AMAC1, TGFβ), among subjects with or without iron overload
次要结局
- characteristics of the subjects(at day 1)