Diabetes Mellitus (Type 2), Healthy Participants
Conditions
Keywords
Alb-PRF, Diabetes Mellitus, Epidermal Growth Factor, Insulin Like Growth Factor-1, Interleukin-6, EGF, IGF-1, IL-6, Albumin Platelet Rich Fibrin
Brief 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.
Interventions
PROCEDUREVenous blood sampling and Alb-PRF preparation
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.
Sponsors
Izmir Katip Celebi University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IL-6 Levels in Alb-PRF samples | Baseline (Day 1) | Interleukin-6 (IL-6) levels will be measured in Alb-PRF samples obtained from participants using ELISA. |
| EGF level in Alb-PRF samples | Baseline (Day 1) | Epidermal growth factor (EGF) levels will be measured in Alb-PRF samples obtained from participants using ELISA. |
| IGF-1 level in Alb-PRF samples | Baseline (Day 1) | Insulin-like growth factor-1 (IGF-1) levels will be measured in Alb-PRF samples obtained from participants using ELISA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between age and IL-6 concentration in Alb-PRF samples | Baseline (Day 1) | Correlation between age (years) and IL-6 concentration (pg/mL) in Alb-PRF samples measured using ELISA. |
| Correlation between age and EGF concentration in Alb-PRF samples | Baseline (Day 1) | Correlation between age (years) and EGF concentration (pg/mL) in Alb-PRF samples measured using ELISA. |
| Correlation between age and IGF-1 concentration in Alb-PRF samples | Baseline (Day 1) | Correlation between age (years) and IGF-1 concentration (pg/mL) in Alb-PRF samples measured using ELISA. |
Countries
Turkey (Türkiye)
Outcome results
None listed