Seeking a Link Between the Capacity of Peripheral Mononuclear Cells to Induce Insulin Resistance and the Development of Hyperinsulinemia in a General Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- End-of-study insulinemia
研究概览
简要总结
This is a two-center proof-of-concept study, ancillary to the MetACTIV study, whose objective is to define immune activation profiles from the data of individuals followed by the Caisse Primaire d'Assurance Maladie du Gard (health insurance fund).
The IRACTIV study will include a subset of volunteers from the MetACTIV study for whom a blood sample will be taken as part of the IRACTIV study.
详细描述
The local health insurance fund regularly offers people who have already had a free health check-up the opportunity to re-do a check-up. This invitation will be made as part of the routine, by mail. People who have participated in the MetACTIV study will be asked to participate in the present IRACTIV study ( they will be sent an information note). That way, up to 30 volunteers who previously participated in the MetACTIV study, including 10 for whom a particular profile has been identified will be recruited again in sequence.
On the day of consultation at the Gard health insurance fund, consent will be collected from subjects who have agreed to participate. The participation of the volunteers will be reduced to this single visit and 16 mL of blood will be collected on EDTA for the purpose of this study. As in the previous MetACTIV study, this blood will be transported to the Biological Resource Center at Nîmes University Hospital. From this blood, the plasma will be frozen and stored at -80°C for subsequent determination of insulin levels under the same conditions as for the MetACTIV study. Peripheral blood mononuclear cells will be frozen and, later, cultured at the Institute of Human Genetics in complete medium for 48 hours. The effect of the supernatants of these cultures on Akt phosphorylation in HepG2 cells exposed to 10nM of insulin will then be quantified by two different techniques (Western Blot and ELISA). This effect will be expressed as a percentage of inhibition compared to the phosphorylation of Akt induced by insulin alone. The insulin slope between the measurement performed in the MetACTIV study and this IRACTIV study will also be calculated and compared to the peripheral blood mononuclear cells ability to induce insulin resistance in vitro.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who participated in the MetACTIV study.
- •Profile 2 subgroup-specific inclusion criteria:
- •MetACTIV study individual with a Profile
- •Persons who have given free informed consent.
- •Persons who have signed the consent form.
- •Persons affiliated to or benefiting from a health insurance plan.
- •Adults (≥18 years of age).
排除标准
- •Persons participating in Category 1 research involving human subjects
- •Persons in an exclusion period as determined by another study.
- •Persons under court protection, guardianship or trusteeship.
- •Persons who are incapable of giving consent.
- •Persons for whom it is impossible to give clear information.
- •Pregnant, parturient or breastfeeding woman.
结局指标
主要结局
End-of-study insulinemia
时间窗: Month 18
The amount of insulin in the blood of patients will be measured during a routine health evaluation and measured in µU/L.
Effect of peripheral blood mononuclear cell supernatant on intensity of the signal induced by insulin in hepatocytes.
时间窗: Hour 48
Peripheral blood mononuclear cells are isolated on a Ficoll gradient and frozen. These frozen peripheral blood mononuclear cells will be sent to the Institute of Human Genetics for culture and supernatants will be recovered after 48 hours. The effect of these supernatants on insulin signaling will then be tested. To do so, they will be added or not to cultured HepG2 cells stimulated 24 hours later by 10nM insulin. After stimulation, HepG2 cells will be lysed and their total Akt and phosphorylated Akt content measured by ELISA and Western Blot. The proportion of phosphorylated Akt in HepG2 cells exposed to peripheral blood mononuclear cells supernatant will be compared with the proportion of phosphorylated Akt in HepG2 cells not exposed to peripheral blood mononuclear cells supernatant and expressed as the percentage of insulin signaling inhibition induced by the peripheral blood mononuclear cells supernatant.
Fasting blood glucose
时间窗: Day 0
Fasting blood glucose will be measured during a routine health evaluation and measured in mM/L.
次要结局
- A. Percentage inhibition of Akt phosphorylation in Profile 2 patients compared with other immune profiles.(Hour 48)
- B. Increase in insulinemia over time in Profile 2 patients compared with other immune profiles.(Month 18)