The Role of Visfatin in Obesity and Periodontal Disease

NCT ID: NCT03470987

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-09-30

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 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.

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.

Conditions

Obesity; Periodontitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1:nO-Ctrl

Non-obese patients without generalized chronic periodontitis who were undergone Phase I periodontal therapy

Phase I Periodontal therapy

Intervention Type: PROCEDURE

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

Phase I Periodontal therapy

Intervention Type: PROCEDURE

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

Phase I Periodontal therapy

Intervention Type: PROCEDURE

Oral hygiene instuction, scaling and root planning

Metabolic control

Intervention Type: DIETARY_SUPPLEMENT

Calorie restricted diet

Group 4: O-CP

Obese patients with generalized chronic periodontitis who were undergone metbolic control and Phase I periodontal therapy

Phase I Periodontal therapy

Intervention Type: PROCEDURE

Oral hygiene instuction, scaling and root planning

Metabolic control

Intervention Type: DIETARY_SUPPLEMENT

Calorie restricted diet

Interventions

Phase I Periodontal therapy

Oral hygiene instuction, scaling and root planning

Intervention Type: PROCEDURE

Metabolic control

Calorie restricted diet

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Deniz Cetiner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deniz Cetiner, Prof

Role: STUDY_CHAIR

Gazi University Faculty of Dentistry Department of Periodontology

Locations

Gazi University Faculty of Dentistry

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Keller A, Rohde JF, Raymond K, Heitmann BL. Association between periodontal disease and overweight and obesity: a systematic review. J Periodontol. 2015 Jun;86(6):766-76. doi: 10.1902/jop.2015.140589. Epub 2015 Feb 12.

Reference Type: BACKGROUND

PMID: 25672656 (View on PubMed)

Suvan J, D'Aiuto F, Moles DR, Petrie A, Donos N. Association between overweight/obesity and periodontitis in adults. A systematic review. Obes Rev. 2011 May;12(5):e381-404. doi: 10.1111/j.1467-789X.2010.00808.x. Epub 2011 Feb 23.

Reference Type: BACKGROUND

PMID: 21348914 (View on PubMed)

Al-Zahrani MS, Bissada NF, Borawskit EA. Obesity and periodontal disease in young, middle-aged, and older adults. J Periodontol. 2003 May;74(5):610-5. doi: 10.1902/jop.2003.74.5.610.

Reference Type: BACKGROUND

PMID: 12816292 (View on PubMed)

Goncalves TE, Zimmermann GS, Figueiredo LC, Souza Mde C, da Cruz DF, Bastos MF, da Silva HD, Duarte PM. Local and serum levels of adipokines in patients with obesity after periodontal therapy: one-year follow-up. J Clin Periodontol. 2015 May;42(5):431-9. doi: 10.1111/jcpe.12396. Epub 2015 Apr 30.

Reference Type: BACKGROUND

PMID: 25858047 (View on PubMed)

Zimmermann GS, Bastos MF, Dias Goncalves TE, Chambrone L, Duarte PM. Local and circulating levels of adipocytokines in obese and normal weight individuals with chronic periodontitis. J Periodontol. 2013 May;84(5):624-33. doi: 10.1902/jop.2012.120254. Epub 2012 Jul 27.

Reference Type: BACKGROUND

PMID: 22839694 (View on PubMed)

Trayhurn P, Beattie JH. Physiological role of adipose tissue: white adipose tissue as an endocrine and secretory organ. Proc Nutr Soc. 2001 Aug;60(3):329-39. doi: 10.1079/pns200194.

Reference Type: BACKGROUND

PMID: 11681807 (View on PubMed)

Balli U, Ongoz Dede F, Bozkurt Dogan S, Gulsoy Z, Sertoglu E. Chemerin and interleukin-6 levels in obese individuals following periodontal treatment. Oral Dis. 2016 Oct;22(7):673-80. doi: 10.1111/odi.12520. Epub 2016 Jul 11.

Reference Type: BACKGROUND

PMID: 27265537 (View on PubMed)

Vazquez-Vela ME, Torres N, Tovar AR. White adipose tissue as endocrine organ and its role in obesity. Arch Med Res. 2008 Nov;39(8):715-28. doi: 10.1016/j.arcmed.2008.09.005.

Reference Type: BACKGROUND

PMID: 18996284 (View on PubMed)

Wozniak SE, Gee LL, Wachtel MS, Frezza EE. Adipose tissue: the new endocrine organ? A review article. Dig Dis Sci. 2009 Sep;54(9):1847-56. doi: 10.1007/s10620-008-0585-3. Epub 2008 Dec 4.

Reference Type: BACKGROUND

PMID: 19052866 (View on PubMed)

Kloting N, Bluher M. Adipocyte dysfunction, inflammation and metabolic syndrome. Rev Endocr Metab Disord. 2014 Dec;15(4):277-87. doi: 10.1007/s11154-014-9301-0.

Reference Type: BACKGROUND

PMID: 25344447 (View on PubMed)

Costford SR, Bajpeyi S, Pasarica M, Albarado DC, Thomas SC, Xie H, Church TS, Jubrias SA, Conley KE, Smith SR. Skeletal muscle NAMPT is induced by exercise in humans. Am J Physiol Endocrinol Metab. 2010 Jan;298(1):E117-26. doi: 10.1152/ajpendo.00318.2009. Epub 2009 Nov 3.

Reference Type: BACKGROUND

PMID: 19887595 (View on PubMed)

Ritchie CS. Obesity and periodontal disease. Periodontol 2000. 2007;44:154-63. doi: 10.1111/j.1600-0757.2007.00207.x. No abstract available.

Reference Type: BACKGROUND

PMID: 17474931 (View on PubMed)

Other Identifiers

OBESITY

Identifier Type: -

Identifier Source: org_study_id