Comparative Evaluation of the Inflammatory Status of Visceral Adipose Tissue From Obese Patients According to the Presence and Severity of Periodontitis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 122
- Locations
- 2
- Primary Endpoint
- Inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient eligible for bariatric surgery scheduled within the digestive surgery
- •Patient affiliated to Social Security system or equivalent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis
Time Frame: 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 )
Secondary Outcomes
- 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))