PeriodontitisNCT05449821
Investigation of Asprosin a Novel Adipokine in Periodontitis
An observational study of Periodontitis and Obesity, 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 18 to 60 years
- Conditions the study is for
- Periodontitis, Obesity, Diabetes Mellitus
- What is being tested?
- Serum and salivary samples will be collected. Asprosin levels will be determined by biochemical analysis
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Dec 2022
- 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 18 to 60 years
- All sexes
- Adult
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
Who may be able to join
- All individuals were generally healthy,
- non-smoking
Who cannot join
- 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 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.
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. 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.
- Conditions
- Periodontitis, Obesity, Diabetes Mellitus
- Being tested
- Serum and salivary samples will be collected. Asprosin levels will be determined by biochemical analysis
- Medical subject headings
- Periodontitis, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum and salivary samples will be collected. Asprosin levels will be determined by biochemical analysisDiagnostic test
Serum and saliva samples will be collected from both groups for biochemical analysis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Serum and salivary 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 and saliva samples obtained
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 posted8 Jul 2022
- Study start1 Jan 2022
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
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 PeriodontitisStudies 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
- 65 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
- Didem Özkal Eminoğlu, Asist. Prof., Study chair, Atatürk University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449821
- Sponsor's protocol ID
- MIC2
- Status last verified
- Jan 2023
- First submitted
- 5 Jul 2022
- Last updated
- 1 Feb 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum and Saliva Asprosin Levels Are Associated With Periodontitis
- ClinicalTrials.gov ID
- NCT05449821
- Acronym / sponsor ID
- MIC2
- Conditions
- Periodontitis, Obesity, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 8 Jul 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 obesity, T2DM and periodontitis.we postulated that asprosin may be candidate for explaining the triangular relationship among obesity, T2DM, 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. 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontitis group | – | Diagnostic Test: Serum and salivary samples will be collected. Asprosin levels will be determined by biochemical analysis35 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. |
| Healthy group | – | Diagnostic Test: Serum and salivary samples will be collected. Asprosin levels will be determined by biochemical analysis30 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- All individuals were generally healthy,
- non-smoking
Key exclusion criteria (3 listed)
- 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 and salivary samples will be collected. Asprosin levels will be determined by biochemical analysisSerum and saliva samples will be collected from both groups for biochemical analysis. | Diagnostic test | Healthy group, Periodontitis group |
Primary outcome
Asprosin Levels
Time frame: two weeks
Determination of asprosin levels by making biochemical analyzes from serum and saliva samples obtained
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 1 Feb 2023.
- Background: 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.
- Background: 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.
Didem Özkal Eminoğlu, Asist. Prof. study chair
Atatürk University, Faculty of Dentistry
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 Periodontitis and Obesity, 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 2 inclusion and 3 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 1 Feb 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 NCT05449821, 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 1 Feb 2023.