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Completed
NCT07672652
Effect of Type 2 Diabetes on Biomarker Levels in Albumin Platelet-Rich Fibrin
Conditions: Healthy Participants, Diabetes Mellitus (Type 2)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 20
Sponsor: Izmir Katip Celebi University
Location: İzmir Katip Çelebi University Izmir Cigli
Summary
Diabetes mellitus is a metabolic disease that can negatively affect wound healing and tissue repair. Albumin platelet-rich fibrin (Alb-PRF) is a blood-derived biomaterial used in periodontal and regenerative treatments. It contains growth factors and cytokines that may support tissue healing.
The purpose of this study is to evaluate whether type 2 diabetes affects the biological composition of Alb-PRF. For this purpose, Alb-PRF samples obtained from individuals with type 2 diabetes will be compared with samples obtained from systemically healthy individuals.
A total of 20 participants will be included in the study: 10 individuals with type 2 diabetes and 10 systemically healthy individuals. Venous blood samples will be collected from each participant, and Alb-PRF will be prepared using a standardized protocol. The prepared samples will be stored at -80°C until laboratory analysis.
The levels of interleukin-6 (IL-6), epidermal growth factor (EGF), and insulin-like growth factor-1 (IGF-1) in Alb-PRF samples will be measured using an enzyme-linked immunosorbent assay (ELISA). These markers are related to inflammation, tissue repair, and wound healing. The results will help determine whether type 2 diabetes changes the cytokine and growth factor profile of Alb-PRF.
Eligibility Criteria
Inclusion Criteria:
For the type 2 diabetes group:
* Diagnosis of type 2 diabetes
* HbA1c value of at least 7%
* Age over 18 years
* Non-smoker
* No use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids within the last 6 months
* Not pregnant or lactating
* Willingness to participate in the study and signing of the informed consent form
For the systemically healthy group:
* No history of diabetes or prediabetes
* Age over 18 years
* Non-smoker
* No use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids within the last 6 months
* Not pregnant or lactating
* Willingness to participate in the study and signing of the informed consent form
Exclusion Criteria:
* Age under 18 years
* Pregnancy or lactation
* Use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids within the last 6 months
* Smoking
* Refusal to participate in the study or not signing the informed consent form
Source: ClinicalTrials.gov (NCT07672652). StuddyBuddy aggregates publicly available trial information.