ParodontitisBACTERIOBNCT02853734
Inflammatory Status of Visceral Adipose Tissue in Obese Patients Related to Periodontitis Severity
A study testing SEVERE PERIODONTITIS and NO PERIODONTITIS in people with Parodontitis and Obesity, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parodontitis, Obesity, Metabolism Disorders
- What is being tested?
- SEVERE PERIODONTITIS and NO PERIODONTITIS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteReunion
- Study dates
- 12 Mar 2019to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient eligible for bariatric surgery scheduled within the digestive surgery
- Patient affiliated to Social Security system or equivalent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Reunion1 site, 1 recruiting
- Recruiting
CHU de La Réunion
Saint-Pierre, 97448
Nathalie LE-MOULLEC, MD, +262(0)262359164, nathalie.lemoullec@chu-reunion.fr
Nathalie LE MOULLEC, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Parodontitis, Obesity, Metabolism Disorders
- Being tested
- SEVERE PERIODONTITIS, NO PERIODONTITIS
- Medical subject headings
- Dry Socket, Obesity, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEVERE PERIODONTITISOther
Patients exhibiting moderate to severe periodontitis
NO PERIODONTITISOther
Patients without existing periodontitis or exhibiting mild periodontitis
| Study group | Role | What they receive |
|---|---|---|
| SEVERE PERIODONTITIS | Experimental | Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue Receives: Other: SEVERE PERIODONTITIS |
| NO PERIODONTITIS | Other | Periodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue Receives: Other: NO PERIODONTITIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 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
Aggregatibacter actinomycetemcomitans, Fusibacterium nucleatum, Porphyromonas gingivalis, Prevotella intermedia, Treponema denticola and Tannerella forsythia
Measured: 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
Measured: 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
Measured: 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
Measured: Consecutively to periodontal examination and fat biopsy (day before surgery, day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start12 Mar 2019
- Primary completionJul 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853734
- Sponsor's protocol ID
- 2015/CHU/13
- Acronym
- BACTERIOB
- Status last verified
- Mar 2020
- First submitted
- 26 Jul 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Inflammatory Status of Visceral Adipose Tissue From Obese Patients According to the Presence and Severity of Periodontitis
- ClinicalTrials.gov ID
- NCT02853734
- Acronym / sponsor ID
- BACTERIOB / 2015/CHU/13
- Conditions
- Parodontitis, Obesity, Metabolism Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEVERE PERIODONTITIS | Experimental | Other: SEVERE PERIODONTITISPeriodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue |
| NO PERIODONTITIS | Other | Other: NO PERIODONTITISPeriodontal examination Biological samples collection: periodontal, saliva, blood, fecal, visceral adipose tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient eligible for bariatric surgery scheduled within the digestive surgery
- Patient affiliated to Social Security system or equivalent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEVERE PERIODONTITISPatients exhibiting moderate to severe periodontitis | Other | SEVERE PERIODONTITIS |
| NO PERIODONTITISPatients without existing periodontitis or exhibiting mild periodontitis | Other | NO PERIODONTITIS |
Primary outcome
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 )
4 secondary outcomes
Detection of DNA for at least one type of periodontal pathogens in adipose tissue
Time frame: Consecutively to visceral fat biopsy (day of surgery)
Description of the metabolic profile of patients relative to periodontitis severity
Time frame: Consecutively to periodontal examination (day before surgery)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEVERE PERIODONTITIS and NO PERIODONTITIS in people with Parodontitis and Obesity, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie TECHER (+262(0)262906289, emilie.techer@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.