Investigation of Asprosin a Novel Adipokine in Periodontitis

October 28, 2022 updated by: Sema Nur Sevinc, Ataturk University

Serum and Saliva Asprosin Levels Are Associated With Periodontitis

Asprosin, a recently discovered glucogenic adipokine, is mainly synthesized by white adipose tissue and released during fasting. Appetite, glucose metabolism, insulin resistance, cell apoptosis, etc. asprosin is associated with diseases such as diabetes, obesity, polycystic ovary syndrome, and cardiovascular diseases. Periodontal tissue may act as a source of endocrine-like inflammatory mediators (such as TNF-α, IL-6 and IL-1) that are important in periodontal inflammation and can affect glucose and lipid metabolism. Production of TNF-α and IL-6 in adipose tissues strengthens the relationship between obesity, T2DM and periodontitis.we postulated that asprosin may be candidate for explaining the triangular relationship among obesity, T2DM, and periodontal disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Periodontal disease is a chronic, multifactorial, and infectious disease caused by bacteria. It is characterized by the formation of an inflammatory response in the supporting bone and connective tissue against microbial dental plaque, and the nature of the resulting inflammatory response determines the course of periodontal disease. Type 2 Diabetes Mellitus (T2DM), obesity, and periodontal disease are closely related, presenting a triad association. Obesity is the crucial cause of T2DM and periodontitis is the sixth complication of diabetes. Asprosin circulates in the blood at nanomolar levels and is taken to the liver, where it activates the G protein-cAMP-PKA pathway, causing rapid glucose release into the circulation. Insulin-resistant humans and mice have been reported to have pathologically elevated plasma asprosin levels. It will be investigated whether asprosin, which we know to be effective on glucose metabolism, is affected by the periodontal condition.

Study Type

Observational

Enrollment (Anticipated)

65

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
      • Erzurum, Turkey, 25240
        • Recruiting
        • Atatürk University Faculty of Dentistry
        • Contact:

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

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All systemically healthy individuals between the ages of 18-60, who applied to the Atatürk University Faculty of Dentistry for periodontal examination, will be evaluated in the study. Patients who consent to participate in the study on a randomized basis and comply with the inclusion criteria will be divided into periodontitis and healthy groups after the periodontal examination. Body mass index will also be evaluated

Description

Inclusion Criteria: -

  • All individuals were generally healthy,
  • non-smoking

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • None had undergone periodontal therapy and/or antibiotic therapy in the past 6 months.
  • None has a contagious disease such as HIV or AIDS

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Periodontitis group
35 subjects had periodontitis. Periodontitis will be staged by including patients with a periodontal pocket (PD) measurement of 4 mm and above, accompanied by attachment loss and radiographic bone loss.
Diagnostic test: Serum and salivary samples will be collected. Asprosin levels will be determined by biochemical analysis
Serum and saliva samples will be collected from both groups for biochemical analysis.
Healthy group
30 subjects had healthy periodontal tissue.Healthy controls included volunteers with clinically healthy gingiva on an intact periodontium who had BOP < 10% and PD ≤ 3 mm, no sites with attachment loss, no radiographic sign of alveolar bone destruction, and no history of periodontitis.
Diagnostic test: Serum and salivary samples will be collected. Asprosin levels will be determined by biochemical analysis
Serum and saliva samples will be collected from both groups for biochemical analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asprosin Levels
Time Frame: two weeks
Determination of asprosin levels by making biochemical analyzes from serum and saliva samples obtained
two weeks

Collaborators and Investigators

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

Sponsor

Ataturk University

Investigators

  • Study Chair: Didem Özkal Eminoğlu, Asist. Prof., Atatürk University, Faculty of Dentistry

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)

January 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIC2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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