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

Primary Purpose

Parodontitis, Obesity, Metabolism Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
SEVERE PERIODONTITIS
NO PERIODONTITIS
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de La RéunionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

SEVERE PERIODONTITIS

NO PERIODONTITIS

Arm Description

Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue

Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue

Outcomes

Primary Outcome Measures

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 )

Secondary Outcome Measures

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
Description of the metabolic profile of patients relative to periodontitis severity
glycemia, insulinemia, glucose tolerance, plasma and HDL total cholesterol, triglycerides
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
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

Full Information

First Posted
July 26, 2016
Last Updated
March 3, 2020
Sponsor
Centre Hospitalier Universitaire de la Réunion
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1. Study Identification

Unique Protocol Identification Number
NCT02853734
Brief Title
Inflammatory Status of Visceral Adipose Tissue in Obese Patients Related to Periodontitis Severity
Acronym
BACTERIOB
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parodontitis, Obesity, Metabolism Disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEVERE PERIODONTITIS
Arm Type
Experimental
Arm Description
Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue
Arm Title
NO PERIODONTITIS
Arm Type
Other
Arm Description
Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue
Intervention Type
Other
Intervention Name(s)
SEVERE PERIODONTITIS
Intervention Description
Patients exhibiting moderate to severe periodontitis
Intervention Type
Other
Intervention Name(s)
NO PERIODONTITIS
Intervention Description
Patients without existing periodontitis or exhibiting mild periodontitis
Primary Outcome Measure Information:
Title
Inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis
Description
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 )
Time Frame
Consecutively to visceral fat biopsy (day of surgery)
Secondary Outcome Measure Information:
Title
Detection of DNA for at least one type of periodontal pathogens in adipose tissue
Description
Aggregatibacter actinomycetemcomitans, Fusibacterium nucleatum, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola and Tannerella forsythia
Time Frame
Consecutively to visceral fat biopsy (day of surgery)
Title
Description of the metabolic profile of patients relative to periodontitis severity
Description
glycemia, insulinemia, glucose tolerance, plasma and HDL total cholesterol, triglycerides
Time Frame
Consecutively to periodontal examination (day before surgery)
Title
Link between adipose tissue inflammatory status, bacterial contamination and metabolic profile of patients
Description
adipose tissue inflammatory status, periodontal bacterial contamination,diabetic disorders, lipid metabolic profile of patients
Time Frame
Consecutively to periodontal examination and fat biopsy (day before surgery, day of surgery)
Title
Link between the presence of periodontal pathogens in adipose tissue and their detection in saliva and plasma
Description
Detection of antibodies directed to periodontal bacteria in saliva and plasma
Time Frame
Consecutively to periodontal examination and fat biopsy (day before surgery, day of surgery)
Other Pre-specified Outcome Measures:
Title
Collection of biological samples
Description
Plasma, saliva and adipose tissue.
Time Frame
Consecutively to samples collection (day before surgery, day of surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie TECHER
Phone
+262(0)262906289
Email
emilie.techer@chu-reunion.fr
Facility Information:
Facility Name
CHU de La Réunion
City
Saint-Pierre
ZIP/Postal Code
97448
Country
Réunion
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie LE-MOULLEC, MD
Phone
+262(0)262359164
Email
nathalie.lemoullec@chu-reunion.fr
First Name & Middle Initial & Last Name & Degree
Nathalie LE MOULLEC, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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