Comparative Evaluation of the Inflammatory Status of Visceral Adipose Tissue From Obese Patients According to the Presence and Severity of Periodontitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis
研究概览
简要总结
The research aims to compare the inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis, in order to establish a potential causal link between the severity of the bacterial contamination and insulin resistance.
详细描述
Recruitment of patients will be achieved in the department of digestive surgery. It will involve 122 patients with severe obesity undergoing bariatric surgery scheduled within the digestive surgery department. Patients recruited will be examined for evaluating the presence and severity of periodontitis, and separated into either group 1: for patients with moderate or severe periodontitis, and or group 2: for patients without or with mild periodontitis. The day before the surgery, blood sample will be collected for the analysis of circulating metabolic and inflammatory markers. Collection of stimulated saliva, periodontal sample and faeces samples (50 g) will also be carried out for bacteria determination. During the surgical procedure, a sample of visceral adipose tissue (50 g) will be collected and used for periodontal bacteria detection and inflammatory markers analyses.
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
- Double (Participant, Investigator)
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
- •Patient eligible for bariatric surgery scheduled within the digestive surgery
- •Patient affiliated to Social Security system or equivalent
排除标准
- •Treatment with steroids or anti-inflammatory drugs in progress (or stopped for less than one month)
- •Patients who received antibiotics within 3 months prior to the bariatric surgery for whatever duration
- •Dental current (or older than 3 months)
- •Participation in another research protocol
结局指标
主要结局
Inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis
时间窗: Consecutively to visceral fat biopsy (day of surgery)
Measurements of major adipocytokines (Interleukine 6, Leptin, Adiponectin, Tumor Necrosis Factor-alpha, Monocyte Chemoattractant Protein-1, macrophage F4/80 receptor, CD11c, nuclear factor-kappa B, Toll Like Receptor 2/4 )
次要结局
- Detection of DNA for at least one type of periodontal pathogens in adipose tissue(Consecutively to visceral fat biopsy (day of surgery))
- Link between adipose tissue inflammatory status, bacterial contamination and metabolic profile of patients(Consecutively to periodontal examination and fat biopsy (day before surgery, day of surgery))
- Description of the metabolic profile of patients relative to periodontitis severity(Consecutively to periodontal examination (day before surgery))
- Link between the presence of periodontal pathogens in adipose tissue and their detection in saliva and plasma(Consecutively to periodontal examination and fat biopsy (day before surgery, day of surgery))