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

Obesity Clinical Trial

— BACTERIOB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02853734
• Other study ID #: 2015/CHU/13
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2019
• Est. completion date: July 2021

Study information

• Verified date: March 2020
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Emilie TECHER
• Phone: +262(0)262906289
• Email: emilie.techer[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: July 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Metabolism Disorders
• Obesity
• Parodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Réunion	CHU de La Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Collection of biological samples	Plasma, saliva and adipose tissue.	Consecutively to samples collection (day before surgery, day of surgery)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)