NCT05647902

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 cardiovascular diseases and periodontitis. Investigators postulated that asprosin may be a candidate for explaining the triangular relationship between cardiovascular and periodontal disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 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
11 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

December 4, 2022

Last Update Submit

July 19, 2023

Conditions

Cardiovascular DiseasesPeriodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • Asprosin Levels

    Determination of asprosin levels by making biochemical analyzes from serum

    two weeks

Study Arms (2)

Healthy Group

70 systemically healthy patients; 35 healthy gingiva is divided into 2 subgroups, 35 of which are periodontitis. Asprosin levels will be examined biochemically in serum samples taken from patients.

Diagnostic Test: Serum samples will be collected. Asprosin levels will be determined by biochemical analysis

Myocard Infactus Group

50 patients with myocardial infarction; 25 healthy gingiva is divided into 2 subgroups, 25 of which are periodontitis. Asprosin levels will be examined biochemically in serum samples taken from patients.

Diagnostic Test: Serum samples will be collected. Asprosin levels will be determined by biochemical analysis

Interventions

Serum samples will be collected. Asprosin levels will be determined by biochemical analysisDIAGNOSTIC_TEST

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

Healthy GroupMyocard Infactus Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study was carried out on 120 patients, 50 admitted to Atatürk University Medical Faculty Heart Center with SD elevation myocardial infarction and 70 who applied to Atatürk University Faculty of Dentistry. Patients who consent to participate in the study on a randomized basis and comply with the inclusion criteria are divided into periodontitis and healthy groups after the periodontal examination. Body mass index was evaluated

You may qualify if:

  • For Healthy group
  • All individuals were generally healthy,
  • non-smoking For Myocard Infarctus group
  • patients with ST elevation of Myocardial Infactus
  • patient with less than ten teeth

You may not qualify if:

  • Smokers or those with diabetes or other inflammatory disease
  • 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: 27087445RESULT

  • 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: 32153505RESULT

MeSH Terms

Conditions

Cardiovascular DiseasesPeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Oğuzhan Birdal, Asist. Prof.

    Ataturk University

    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

December 4, 2022

First Posted

December 13, 2022

Study Start

January 1, 2022

Primary Completion

December 30, 2022

Study Completion

January 1, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

TU(1)