NCT02853734

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
2.6 years until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

July 26, 2016

Last Update Submit

March 3, 2020

Conditions

ParodontitisObesityMetabolism Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Detection of DNA for at least one type of periodontal pathogens in adipose tissue

    Consecutively to visceral fat biopsy (day of surgery)

  • Description of the metabolic profile of patients relative to periodontitis severity

    Consecutively to periodontal examination (day before surgery)

  • 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)

  • 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)

Other Outcomes (1)

  • Collection of biological samples

    Consecutively to samples collection (day before surgery, day of surgery)

Study Arms (2)

SEVERE PERIODONTITIS

EXPERIMENTAL

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

Other: SEVERE PERIODONTITIS

NO PERIODONTITIS

OTHER

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

Other: NO PERIODONTITIS

Interventions

SEVERE PERIODONTITISOTHER

Patients exhibiting moderate to severe periodontitis

SEVERE PERIODONTITIS
NO PERIODONTITISOTHER

Patients without existing periodontitis or exhibiting mild periodontitis

NO PERIODONTITIS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient eligible for bariatric surgery scheduled within the digestive surgery
  • Patient affiliated to Social Security system or equivalent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de La Réunion

Saint-Pierre, 97448, Reunion

RECRUITING

MeSH Terms

Conditions

Dry SocketObesityMetabolic Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Emilie TECHER

CONTACT

+262(0)262906289emilie.techer@chu-reunion.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 3, 2016

Study Start

March 12, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2021

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

RE(1)