Viewing Study NCT03470987



Ignite Creation Date: 2024-05-06 @ 11:15 AM
Last Modification Date: 2024-10-26 @ 12:42 PM
Study NCT ID: NCT03470987
Status: COMPLETED
Last Update Posted: 2018-03-21
First Post: 2018-03-06

Brief Title: The Role of Visfatin in Obesity and Periodontal Disease
Sponsor: Gazi University
Organization: Gazi University

Study Overview

Official Title: The Role of Visfatin Levels in Gingival Crevicular Fluid as Potential Biomarker in The Relationship Between Obesity and Periodontal Disease
Status: COMPLETED
Status Verified Date: 2018-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 obesenon-obese patients withwithout generalized chronic periodontitis GCP Patients were categorized as obese O n31 or non-obese nO n19 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
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 kgheight in meters2 is 25 and obese if BMI 30 kgm2 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None