Type 2 Diabetes and Alteration of Immune System of Intestinal Mucosa : Proof of Concept
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Number of lymphocyte TCD4 Th17 in colon sample
研究概览
简要总结
Type 2 diabetes is the predominant type of diabetes. Because a quiet evolution, it is difficult to have a rapid diagnose. A better knowledge about pathophysiological mechanisms at the origin of type 2 diabetes and about its complications could make it possible to improve the prevention and the treatment of this disease.
Research team developped a new research axis : the microbiota of the intestinal mucosa. They proved a translocation process of intestinal bacteria from the intestinal mucosa to different tissue of the organism implicated in glucose homeostasis. This mechanism is involved in the type 2 diabetes development. A clinical study (MICIMAB) of predictive biomarkers of diabetes and obesity is ongoing.
In parallel, the same team explored the role of intestinal immunity modifications in the bacteria translocation from the gut to the blood circulation. They already have some results on animal model but not yet in human. In animal model, a solid reduction of lymphocytes T CD4 Th17 in the intestinal wall is responsable of the translocation of intestinal bacteria and in the induction of a metabolic inflammation wich promotes insulin resistance, abdominal obesity development and type 2 diabetes.
The aim of this study is to explore this hypothesis in human to have therapeutic solution later.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Coloscopy indication
- •Capacity to give a written informed consent
排除标准
- •Type 1 diabetes
- •Severe renal failure
- •Antecedent of liver fibrosis and/or liver failure
- •Antecedent of inflammatory bowel disease, lymphocyte colitis, celiac disease or colon cancer
- •Antecedent of obesity surgery or of total colectomy
- •Antecedent of documented intestinal ischaemia
- •Acute infection the week before the inclusion
- •Congenital of acquired immune deficiency
- •Chronic viral infection
- •Antibiotic of probiotic the month before the coloscopy
- •Pregnancy
- •Patients participating to another research with an exclusion period
- •Patients under guardianship
结局指标
主要结局
Number of lymphocyte TCD4 Th17 in colon sample
时间窗: Day 1
After colon biopsy, lymphocytes TCD4 Th17 are counted in biopsy sample.
次要结局
- Number of CD45+ cells in ileon sample(Day 1)
- Microbiota sequencing in colon sample(Day 1)
- Microbiota quantification in ileon sample(Day 1)
- Number of CD45+ cells in colon sample(Day 1)
- Number of lymphocyte TCD4 Th17 in ileon sample(Day 1)
- Microbiota sequencing in blood sample(Day 1)
- Activation of CD45+ cells in colon sample(Day 1)
- Microbiota sequencing in ileon sample(Day 1)
- Microbiota quantification in colon sample(Day 1)
- Bacteria production(Day 1)
- Activation of CD45+ cells in ileon sample(Day 1)
- Microbiota quantification in blood sample(Day 1)