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

Comparative Evaluation of the Inflammatory Status of Visceral Adipose Tissue From Obese Patients According to the Presence and Severity of Periodontitis

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Parodontitis; Metabolism Disorders
• Intervention / Treatment: Other: SEVERE PERIODONTITIS; Other: NO PERIODONTITIS

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 Type: Interventional
• Enrollment (Anticipated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilie TECHER; Phone Number: +262(0)262906289; Email: emilie.techer@chu-reunion.fr

Study Locations

• Réunion
  • Saint-Pierre, Réunion, 97448
    • Recruiting
    • CHU de la Réunion
    • Contact: Nathalie LE-MOULLEC, MD; Phone Number: +262(0)262359164; Email: nathalie.lemoullec@chu-reunion.fr
    • Principal Investigator: Nathalie LE MOULLEC, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEVERE PERIODONTITIS; Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue	Other: SEVERE PERIODONTITIS; Patients exhibiting moderate to severe periodontitis
Other: NO PERIODONTITIS; Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue	Other: NO PERIODONTITIS; Patients without existing periodontitis or exhibiting mild periodontitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis	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 )	Consecutively to visceral fat biopsy (day of surgery)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of biological samples	Plasma, saliva and adipose tissue.	Consecutively to samples collection (day before surgery, day of surgery)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 3, 2016

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Metabolic Diseases
• Other Study ID Numbers: 2015/CHU/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No