Inflammatory Status of Visceral Adipose Tissue in Obese Patients Related to Periodontitis Severity

Not Applicable

• Conditions: Parodontitis; Obesity; Metabolism Disorders
• Interventions: Other: NO PERIODONTITIS; Other: SEVERE PERIODONTITIS

• Registration Number: NCT02853734
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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 Timeline

• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-03
• Study Start: 2019-03-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04
• Primary Completion: 2020-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NO PERIODONTITIS	NO PERIODONTITIS	Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue
SEVERE PERIODONTITIS	SEVERE PERIODONTITIS	Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue

Primary Outcome Measures

Name	Time	Method
Inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis	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 Outcome Measures

Name	Time	Method
Description of the metabolic profile of patients relative to periodontitis severity	Consecutively to periodontal examination (day before surgery)	glycemia, insulinemia, glucose tolerance, plasma and HDL total cholesterol, triglycerides
Detection of DNA for at least one type of periodontal pathogens in adipose tissue	Consecutively to visceral fat biopsy (day of surgery)	Aggregatibacter actinomycetemcomitans, Fusibacterium nucleatum, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola and Tannerella forsythia
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)	adipose tissue inflammatory status, periodontal bacterial contamination,diabetic disorders, lipid metabolic profile of patients
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)	Detection of antibodies directed to periodontal bacteria in saliva and plasma

Trial Locations

Locations (1)

CHU de La Réunion; 🇷🇪 Saint-Pierre, Réunion