- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05647902
Association of Asprosin in Periodontitis and Acute Coronary Syndrome
July 19, 2023 updated by: Sema Nur Sevinc, Ataturk University
Serum Asprosin Concentrations in Patients With Periodontitis and Acute Coronary Syndrome
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.
Study Overview
Status
Completed
Conditions
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.
Cardiovascular and periodontal diseases are closely related, presenting a triad association.
Asprosin circulates in the blood at nanomolar levels and is taken to the liver, where it activatesinvestigators the G protein-cAMP-PKA pathway, causing rapid glucose release into the circulation.
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Erzurum, Turkey, 25240
- Atatürk University Faculty of Dentistry
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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
14 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability 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
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
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 |
|---|---|
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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.
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Serum samples will be collected from both groups for biochemical analysis.
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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.
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Serum samples will be collected from both groups for biochemical analysis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Asprosin Levels
Time Frame: two weeks
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Determination of asprosin levels by making biochemical analyzes from serum
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two weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Oğuzhan Birdal, Asist. Prof., Ataturk University
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
- 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.
- 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.
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 (Actual)
December 30, 2022
Study Completion (Actual)
January 1, 2023
Study Registration Dates
First Submitted
December 4, 2022
First Submitted That Met QC Criteria
December 4, 2022
First Posted (Actual)
December 13, 2022
Study Record Updates
Last Update Posted (Actual)
July 20, 2023
Last Update Submitted That Met QC Criteria
July 19, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIC3
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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