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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05449821
Other study ID # MIC2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 1, 2022

Study information

Verified date January 2023
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date December 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - - All individuals were generally healthy, - non-smoking Exclusion Criteria: - 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Serum and salivary samples will be collected. Asprosin levels will be determined by biochemical analysis
Serum and saliva samples will be collected from both groups for biochemical analysis.

Locations

Country Name City State
Turkey Atatürk University Faculty of Dentistry Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Asprosin Levels Determination of asprosin levels by making biochemical analyzes from serum and saliva samples obtained two weeks
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