Effect of Type 2 Diabetes on Biomarker Levels in Albumin Platelet-Rich Fibrin
Effect of Type 2 Diabetes on Insulin Like Growth Factor-1, Epidermal Growth Factor and Interleukin-6 Levels in Albumin Platelet-Rich Fibrin Membranes
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Cigli
-
Izmir, Cigli, Tyrkiet (Türkiye), 35620
- Izmir Katip Celebi University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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.
|
|
Eksperimentel: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
IL-6 Levels in Alb-PRF samples
Tidsramme: Baseline (Day 1)
|
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
Tidsramme: Baseline (Day 1)
|
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
Tidsramme: Baseline (Day 1)
|
Insulin-like growth factor-1 (IGF-1) levels will be measured in Alb-PRF samples obtained from participants using ELISA.
|
Baseline (Day 1)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation between age and IL-6 concentration in Alb-PRF samples
Tidsramme: Baseline (Day 1)
|
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
Tidsramme: Baseline (Day 1)
|
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
Tidsramme: Baseline (Day 1)
|
Correlation between age (years) and IGF-1 concentration (pg/mL) in Alb-PRF samples measured using ELISA.
|
Baseline (Day 1)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Metaboliske sygdomme
- Glukosemetabolismeforstyrrelser
- Ernæringsmæssige og metaboliske sygdomme
- Diabetes mellitus, type 2
- Diabetes mellitus
- Undersøgelsesteknikker
- Håndtering af eksemplar
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Punkteringer
- Kirurgiske procedurer, operative
- Blodprøveopsamling
Andre undersøgelses-id-numre
- 2025-SAEK-0034
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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