Clinical trial NCT02853734: Inflammatory Status of Visceral Adipose Tissue in Obese Patients Related to Periodontitis Severity
Official title: Comparative Evaluation of the Inflammatory Status of Visceral Adipose Tissue From Obese Patients According to the Presence and Severity of Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parodontitis
Obesity
Metabolism Disorders
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis
timeFrame: Consecutively to visceral fat biopsy (day of surgery)
Secondary outcomes:
measure: Detection of DNA for at least one type of periodontal pathogens in adipose tissue
timeFrame: Consecutively to visceral fat biopsy (day of surgery)
measure: Description of the metabolic profile of patients relative to periodontitis severity
timeFrame: Consecutively to periodontal examination (day before surgery)
measure: Link between adipose tissue inflammatory status, bacterial contamination and metabolic profile of patients
timeFrame: Consecutively to periodontal examination and fat biopsy (day before surgery, day of surgery)
measure: Link between the presence of periodontal pathogens in adipose tissue and their detection in saliva and plasma
timeFrame: Consecutively to periodontal examination and fat biopsy (day before surgery, day of surgery)
Other outcomes:
measure: Collection of biological samples
timeFrame: Consecutively to samples collection (day before surgery, day of surgery)
Locations:
city: Saint-Pierre
country: Réunion
facility: CHU de La Réunion
Study officials:
References: