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

Overview

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.

Full Title of Study: “Comparative Evaluation of the Inflammatory Status of Visceral Adipose Tissue From Obese Patients According to the Presence and Severity of Periodontitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2020

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.

Interventions

  • Other: SEVERE PERIODONTITIS
    • Patients exhibiting moderate to severe periodontitis
  • Other: NO PERIODONTITIS
    • Patients without existing periodontitis or exhibiting mild periodontitis

Arms, Groups and Cohorts

  • Experimental: SEVERE PERIODONTITIS
    • Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue
  • Other: NO PERIODONTITIS
    • Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de la Réunion
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Emilie TECHER, +262(0)262906289, emilie.techer@chu-reunion.fr

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