Cardiovascular DiseasesNCT05647902
Association of Asprosin in Periodontitis and Acute Coronary Syndrome
An observational study of Cardiovascular Diseases and Periodontal Diseases, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Periodontal Diseases
- What is being tested?
- Serum samples will be collected. Asprosin levels will be determined by biochemical analysis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Dentistry
Erzurum, 25240
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Periodontal Diseases
- Being tested
- Serum samples will be collected. Asprosin levels will be determined by biochemical analysis
- Medical subject headings
- Cardiovascular Diseases, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Serum samples will be collected. Asprosin levels will be determined by biochemical analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asprosin Levels
Determination of asprosin levels by making biochemical analyzes from serum
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Jan 2022
- Primary completion30 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Nur Sevinc, Ataturk University
- Investigators
- Oğuzhan Birdal, Asist. Prof., Study chair, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647902
- Sponsor's protocol ID
- MIC3
- Status last verified
- Jul 2023
- First submitted
- 4 Dec 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 27087445Yuan 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.
PubMed 32153505
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Asprosin Concentrations in Patients With Periodontitis and Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05647902
- Acronym / sponsor ID
- MIC3
- Conditions
- Cardiovascular Diseases, Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Group | – | Diagnostic Test: Serum samples will be collected. Asprosin levels will be determined by biochemical analysis70 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. |
| Myocard Infactus Group | – | Diagnostic Test: Serum samples will be collected. Asprosin levels will be determined by biochemical analysis50 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum samples will be collected. Asprosin levels will be determined by biochemical analysisSerum samples will be collected from both groups for biochemical analysis. | Diagnostic test | Healthy Group, Myocard Infactus Group |
Primary outcome
Asprosin Levels
Time frame: two weeks
Determination of asprosin levels by making biochemical analyzes from serum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Results publication: PubMed 27087445Romere 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.
- Results publication: PubMed 32153505Yuan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oğuzhan Birdal, Asist. Prof. study chair
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Periodontal Diseases, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asprosin Levels (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647902, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.