NCT05449821

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

July 5, 2022

Last Update Submit

January 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Asprosin Levels

    Determination of asprosin levels by making biochemical analyzes from serum and saliva samples obtained

    two weeks

Study Arms (2)

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

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

Interventions

Serum and saliva samples will be collected from both groups for biochemical analysis.

Healthy groupPeriodontitis group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • All individuals were generally healthy,
  • non-smoking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Faculty of Dentistry

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (2)

  • Romere C, Duerrschmid C, Bournat J, Constable P, Jain M, Xia F, Saha PK, Del Solar M, Zhu B, York B, Sarkar P, Rendon DA, Gaber MW, LeMaire SA, Coselli JS, Milewicz DM, Sutton VR, Butte NF, Moore DD, Chopra AR. Asprosin, a Fasting-Induced Glucogenic Protein Hormone. Cell. 2016 Apr 21;165(3):566-79. doi: 10.1016/j.cell.2016.02.063. Epub 2016 Apr 14.

    PMID: 27087445BACKGROUND
  • Yuan M, Li W, Zhu Y, Yu B, Wu J. Asprosin: A Novel Player in Metabolic Diseases. Front Endocrinol (Lausanne). 2020 Feb 19;11:64. doi: 10.3389/fendo.2020.00064. eCollection 2020.

    PMID: 32153505BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva and plasma samples

MeSH Terms

Conditions

PeriodontitisObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Didem Özkal Eminoğlu, Asist. Prof.

    Atatürk University, Faculty of Dentistry

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 8, 2022

Study Start

January 1, 2022

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations