The Role of Visfatin in Obesity and Periodontal Disease

NCT03470987 | Completed

• 1 other identifier: OBESITY
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Periodontitis

Keywords

obesity; periodontitis; cytokines

Outcome Measures

Primary Outcomes (1)

• Cytokine levels in Gingival crevicular fluid

  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 Outcomes (5)

• Clinical attachment level

  Change from baseline clinical attachment level to 3rd month level

• Probing depth

  Change from baseline probing depth value at 3rd month value

• Bleeding on probing

  Change from baseline bleeding on probing score to 3rd month score

• Gingival index

  Change from baseline gingival index score to 3rd month score

• Plaque index

  Change from baseline plaque index score to 3rd month score

Study Arms (4)

Group 1:nO-Ctrl

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

Procedure: Phase I Periodontal therapy

Group 2:nO-CP

Non-obese patients with generalized chronic periodontitis who were undergone Phase I periodontal therapy

Procedure: Phase I Periodontal therapy

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; Dietary Supplement: Metabolic control

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; Dietary Supplement: Metabolic control

Interventions

Phase I Periodontal therapy PROCEDURE

Oral hygiene instuction, scaling and root planning

Group 1:nO-Ctrl; Group 2:nO-CP; Group 3: O-Ctrl; Group 4: O-CP

Metabolic control DIETARY_SUPPLEMENT

Calorie restricted diet

Group 3: O-Ctrl; Group 4: O-CP

Eligibility Criteria

• Age: 20 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Dentistry

Ankara, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 25672656 BACKGROUND

• 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.

  PMID: 21348914 BACKGROUND

• 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.

  PMID: 12816292 BACKGROUND

• 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.

  PMID: 25858047 BACKGROUND

• 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.

  PMID: 22839694 BACKGROUND

• 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.

  PMID: 11681807 BACKGROUND

• 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.

  PMID: 27265537 BACKGROUND

• 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.

  PMID: 18996284 BACKGROUND

• 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.

  PMID: 19052866 BACKGROUND

• 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.

  PMID: 25344447 BACKGROUND

• 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.

  PMID: 19887595 BACKGROUND

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

  PMID: 17474931 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Gingival crevicular fluid

MeSH Terms

Conditions

Obesity; Periodontitis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Deniz Cetiner, Prof

  Gazi University Faculty of Dentistry Department of Periodontology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 20, 2018
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 21, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)