The Role of Visfatin in Obesity and Periodontal Disease

March 20, 2018 updated by: Deniz Cetiner, Gazi University

The Role of Visfatin Levels in Gingival Crevicular Fluid as Potential Biomarker in The Relationship Between Obesity and Periodontal Disease

Visfatin is an adipokine that plays an important role in immune functions as a growth factor, enzyme, and proinflammatory mediator. The investigators aimed to determine the levels of visfatin, interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) in gingival crevicular fluid (GCF) in both obese/non-obese patients, with/without generalized chronic periodontitis (GCP). Patients were categorized as obese (O) (n=31) or non-obese (nO) (n=19). Groups were divided into four subgroups according to periodontal conditions: (1) periodontally healthy without obesity (nO-Ctrl); (2) GCP without obesity (nO-CP); (3) periodontally healthy with obesity (O-Ctrl); and (4) GCP with obesity (O-CP). Demographic variables and anthropometric and laboratory data were recorded. Periodontal measurements were recorded at baseline and 3rd months after either non-surgical periodontal treatment or calorie restricted diet therapy. At the same time GCF samples were taken from patients to analyze TNF-alpha, IL-6, and visfatin levels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Overweightness and obesity are defined as the accumulation of fat in body tissues that might impair overall health. Adults are considered overweight if their body mass index (BMI, calculated as weight in kg/[height in meters]2) is ≥ 25 and obese if BMI ≥ 30 kg/m2. The prevalence of overweightness and obesity has increased worldwide during recent decades.

Obesity is usually related to a chronic low-grade systemic inflammation resulting in significant changes in the concentrations of cytokines and hormones, which subsequently leads to the development of obesity-linked disorders, including insulin resistance, type II diabetes, cardiovascular diseases, dyslipidemia, and metabolic syndrome. Since the host response is among the most crucial factors affecting the pathogenesis of periodontal disease, multiple studies have addressed the possible associations between BMI, overweightness, obesity, diabetes, the serum level of lipids, cholesterol, and periodontal breakdown, with mixed results. Many studies have demonstrated a positive association between obesity and periodontitis and suggested that obesity-related inflammation might promote periodontitis by secretion of inflammatory markers by the adipose tissue, which might subsequently increase gingival inflammation. The association between obesity and periodontal disease is based on the amassing of white adipose tissue (WAT) and increased secretion levels of adipokines from WAT.

WAT is an energy storage organ with some metabolic activities, participating in the endocrine and secretory systems. WAT secretes several immune-modulatory adipokine molecules, such as adiponectin, leptin, visfatin, resistin, chemerin, tumor necrosis factor-alpha (TNF-alpha), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It has been found that these molecules are involved in a wide range of physiologic and pathologic processes, including immunity and inflammation. Thus, cytokines and hormones released from adipose tissue might play a role in the destruction of periodontal tissue by inducing hyperinflammatory responses.

Visfatin is a multi-potential mediator that functions as a growth factor, cytokine, an enzyme with a role in energy metabolism, and as a proinflammatory mediator. It is mainly released from adipose tissue, especially from macrophages, and can also be released from lymphocytes, dendritic, muscle, and bone marrow cells. Visfatin has an important role in the regulation of the immune response. Visfatin inhibits neutrophil apoptosis during inflammation and increases TNF-alpha, IL-1β, and IL-6 levels. The expression of visfatin is increased under inflammatory conditions, such as rheumatoid arthritis, cardiovascular diseases, type-II diabetes mellitus, and periodontal disease.

Although several studies have demonstrated the relationship between periodontitis and obesity, no study has evaluated the levels of visfatin in gingival crevicular fluid (GCF) in obese individuals with periodontitis. Increased adipocytes levels, such as visfatin, cause secretion of cytokines, which are known to play an important role in periodontitis, and might trigger periodontitis formation and development.

Therefore, the main objective of this study was to analyze the levels of visfatin, IL-6, and TNF-alpha in obese and non-obese individuals, with or without generalized chronic periodontitis (GCP). Secondarily, the investigators aimed to evaluate metabolic and clinical periodontal parameters, and also clarify the relationship between these parameters and adipocytokines. The hypothesis is that adipocytokine molecules are involved in the pathogenesis of inflammatory diseases; if true, individuals who are obese with periodontitis would present increased levels of visfatin, IL-6, and TNF-alpha in their GCF.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Gazi University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 68 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The 195 patients diagnosed with obesity in the outpatient clinics of Endocrinology and Metabolic Diseases Department, Ataturk Hospital, Turkey, were potential candidates and were interviewed according to our case definition and invited to be included in the study. Thirty-one of 195 volunteers accepted and signed the informed study protocol and took part in the study. All individuals were thoroughly informed of the nature, potential risks, and benefits of their participation in the study before providing their informed consent.

In the same period, 100 consecutive non-obese patients were screened from the Department of Periodontology, Faculty of Dentistry, Gazi University, Turkey, who were systemically healthy and fulfilled the inclusion criteria, of which 19 agreed to participate.

Description

Inclusion Criteria:

  • having > 22 natural teeth
  • no systemic diseases
  • having good cooperation
  • having BMI > 30
  • waist circumference > 88 cm for females for obese patients
  • waist circumference > 102 cm for males for obese patients
  • age > 20 years

Exclusion Criteria:

  • presence of localized chronic periodontitis
  • received periodontal therapy/surgery in the previous 6 months
  • pregnancy
  • use of any hormone therapy
  • history of antibiotic or anti-inflammatory drugs therapy within the previous 6 months
  • current and former smoker
  • lactation
  • presence of aggressive periodontitis
  • presence of periapical pathologies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1:nO-Ctrl
Non-obese patients without generalized chronic periodontitis who were undergone Phase I periodontal therapy
Procedure: Phase I Periodontal therapy
Oral hygiene instuction, scaling and root planning
Group 2:nO-CP
Non-obese patients with generalized chronic periodontitis who were undergone Phase I periodontal therapy
Procedure: Phase I Periodontal therapy
Oral hygiene instuction, scaling and root planning
Group 3: O-Ctrl
Obese patients without generalized chronic periodontitis who were undergone metabolic control and Phase I periodontal therapy
Procedure: Phase I Periodontal therapy
Oral hygiene instuction, scaling and root planning
Dietary supplement: Metabolic control
Calorie restricted diet
Group 4: O-CP
Obese patients with generalized chronic periodontitis who were undergone metbolic control and Phase I periodontal therapy
Procedure: Phase I Periodontal therapy
Oral hygiene instuction, scaling and root planning
Dietary supplement: Metabolic control
Calorie restricted diet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cytokine levels in Gingival crevicular fluid
Time Frame: Beginning of the study (baseline) and 3 months following Phase I periodontal therapy and metbolic control

Gingival crevicular fluid samples were collected at baseline and repeated at 3rd months following Phase I periodontal therapy and metabolic control.

In the periodontally healthy group, samples were obtained from maxillary anterior four teeth exhibiting probing depth < 3mm without clinical attachment level or bleeding on probing. Four sites from each tooth were used for Gingival crevicular fluid sampling.

In the generalized chronic periodontitis groups, Gingival crevicular fluid samples were collected from four teeth with bleeding on probing, probing depth≥ 5 mm, clinical attachment level≥ 5 mm, and 30% bone loss. Visfatin, TNF alpha and IL-6 levels in these fluid samples were determined using an enzyme-linked immunosorbent assay (ELISA).
Beginning of the study (baseline) and 3 months following Phase I periodontal therapy and metbolic control

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical attachment level
Time Frame: Change from baseline clinical attachment level to 3rd month level
Clinical attachment level which is the position of the soft tissue in relation to the cemento-enamel junction was noted from all teeth, excluding third molars at the baseline and 3 months following Phase I periodontal therapy and metabolic control
Change from baseline clinical attachment level to 3rd month level
Probing depth
Time Frame: Change from baseline probing depth value at 3rd month value
Probing depth was noted from all teeth, excluding third molars, on midbuccal and midlingual sites and the buccal aspects of the interproximal contact area for mesial and distal sites using a William's periodontal probe at baseline and 3 months following Phase I periodontal therapy and metabolic control
Change from baseline probing depth value at 3rd month value
Bleeding on probing
Time Frame: Change from baseline bleeding on probing score to 3rd month score
The presence of bleeding after probing was noted from all teeth, excluding third molars at the baseline and 3 months following Phase I periodontal therapy and metabolic control
Change from baseline bleeding on probing score to 3rd month score
Gingival index
Time Frame: Change from baseline gingival index score to 3rd month score
The gingival index which is a measure of periodontal disease based on the severity and location of the lesion was noted from all teeth, excluding third molars at the baseline and 3 months following Phase I periodontal therapy and metabolic control
Change from baseline gingival index score to 3rd month score
Plaque index
Time Frame: Change from baseline plaque index score to 3rd month score
The plaque index which is an index for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin was noted from all teeth, excluding third molars at the baseline and 3 months following Phase I periodontal therapy and metabolic control
Change from baseline plaque index score to 3rd month score

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Deniz Cetiner, Prof, Gazi University Faculty of Dentistry Department of Periodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Obesity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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