Effect of Type 2 Diabetes on Insulin Like Growth Factor-1, Epidermal Growth Factor and Interleukin-6 Levels in Albumin Platelet-Rich Fibrin Membranes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- IL-6 Levels in Alb-PRF samples
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Age under 18 years
- •Pregnancy or lactation
- •Use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids within the last 6 months
- •Refusal to participate in the study or not signing the informed consent form
研究组 & 干预措施
Type 2 Diabetes Group
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.
干预措施: Venous blood sampling and Alb-PRF preparation (Procedure)
Systemically Healthy Group
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.
干预措施: Venous blood sampling and Alb-PRF preparation (Procedure)
结局指标
主要结局
IL-6 Levels in Alb-PRF samples
时间窗: 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
时间窗: 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
时间窗: Baseline (Day 1)
Insulin-like growth factor-1 (IGF-1) levels will be measured in Alb-PRF samples obtained from participants using ELISA.
次要结局
- Association between age and biomarker levels in Alb-PRF samples(Baseline (Day 1))
- Correlation between age and IL-6 concentration in Alb-PRF samples(Baseline (Day 1))
- Correlation between age and EGF concentration in Alb-PRF samples(Baseline (Day 1))
- Correlation between age and IGF-1 concentration in Alb-PRF samples(Baseline (Day 1))
研究者
Aylin Gizem Altıntaş
Research Assistant
Izmir Katip Celebi University