Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- rDNA comparison between cases and controls
研究概览
简要总结
The investigators will compare 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.
详细描述
Experimental evidence suggests that bacterial translocation from gut to tissue could be an initial step leading to diabetes. To test this hypothesis, a bacterial component that is highly conserved between different species of bacteria, the 16S rDNA gene will be analysed both in intestinal crypt and in blood in patients with type 2 diabetes, obese patients and control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 35 and 75 years old
- •Colonoscopy and biopsies required
- •Diabetes population:
- •Type 2 diabetes
- •Obese population:
- •Android obesity
排除标准
- •Inflammatory bowel disease
- •Colonic cancer
- •Bariatric surgery
- •Previous administration of antibiotic (within 15 days)
- •Pregnancy
研究组 & 干预措施
obese patients
Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
干预措施: obese patients (Other)
Diabetic patients
Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
干预措施: diabetic patients (Other)
Patients free of obesity and diabetes
Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
干预措施: patients free of obesity and diabetes (Other)
patients free type 2 diabetes.
Total blood sample, and 4 biopsies : collection of 2 colonic and 2 ileal biopsies
干预措施: patients free type 2 diabetes (Other)
结局指标
主要结局
rDNA comparison between cases and controls
时间窗: 36 months
Comparison of 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.
次要结局
未报告次要终点