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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 Diabetes Group | Experimental | Participants with type 2 diabetes. Venous blood samples will be collected, and Alb-PRF samples will be prepared for the measurement of IL-6, EGF, and IGF-1 levels. |
|
| Systemically Healthy Group | Experimental | Systemically healthy participants without type 2 diabetes. Venous blood samples will be collected, and Alb-PRF samples will be prepared for the measurement of IL-6, EGF, and IGF-1 levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous blood sampling and Alb-PRF preparation | Procedure | Venous blood samples will be collected from participants. Alb-PRF samples will be prepared using a standardized protocol, and IL-6, EGF, and IGF-1 levels will be measured using ELISA. |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6 Levels in Alb-PRF samples | Interleukin-6 (IL-6) levels will be measured in Alb-PRF samples obtained from participants using ELISA. | Baseline (Day 1) |
| EGF level in Alb-PRF samples | Epidermal growth factor (EGF) levels will be measured in Alb-PRF samples obtained from participants using ELISA. | Baseline (Day 1) |
| IGF-1 level in Alb-PRF samples | Insulin-like growth factor-1 (IGF-1) levels will be measured in Alb-PRF samples obtained from participants using ELISA. | Baseline (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between age and IL-6 concentration in Alb-PRF samples | Correlation between age (years) and IL-6 concentration (pg/mL) in Alb-PRF samples measured using ELISA. | Baseline (Day 1) |
| Correlation between age and EGF concentration in Alb-PRF samples |
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Inclusion Criteria:
For the type 2 diabetes group:
For the systemically healthy group:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İzmir Katip Çelebi University | Izmir | Cigli | 35620 | Turkey (Türkiye) |
Individual participant data will not be shared due to privacy and ethical restrictions.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Participants will be assigned to two parallel groups: individuals with type 2 diabetes and systemically healthy individuals. Alb-PRF samples obtained from both groups will be analyzed and compared in terms of IL-6, EGF, and IGF-1 levels.
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Correlation between age (years) and EGF concentration (pg/mL) in Alb-PRF samples measured using ELISA. |
| Baseline (Day 1) |
| Correlation between age and IGF-1 concentration in Alb-PRF samples | Correlation between age (years) and IGF-1 concentration (pg/mL) in Alb-PRF samples measured using ELISA. | Baseline (Day 1) |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |