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NCT Number: NCT07672652

Effect of Type 2 Diabetes on Biomarker Levels in Albumin Platelet-Rich Fibrin

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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Key information

Conditions

Healthy Participants Diabetes Mellitus Diabetes Mellitus (Type 2) Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İzmir Katip Çelebi University

Izmir, Cigli, 35620, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. IL-6 Levels in Alb-PRF samples

    Time frame: Baseline (Day 1)

    Interleukin-6 (IL-6) levels will be measured in Alb-PRF samples obtained from participants using ELISA.

  2. EGF level in Alb-PRF samples

    Time frame: Baseline (Day 1)

    Epidermal growth factor (EGF) levels will be measured in Alb-PRF samples obtained from participants using ELISA.

  3. IGF-1 level in Alb-PRF samples

    Time frame: Baseline (Day 1)

    Insulin-like growth factor-1 (IGF-1) levels will be measured in Alb-PRF samples obtained from participants using ELISA.

Secondary outcomes

  1. Correlation between age and IL-6 concentration in Alb-PRF samples

    Time frame: Baseline (Day 1)

    Correlation between age (years) and IL-6 concentration (pg/mL) in Alb-PRF samples measured using ELISA.

  2. Correlation between age and EGF concentration in Alb-PRF samples

    Time frame: Baseline (Day 1)

    Correlation between age (years) and EGF concentration (pg/mL) in Alb-PRF samples measured using ELISA.

  3. Correlation between age and IGF-1 concentration in Alb-PRF samples

    Time frame: Baseline (Day 1)

    Correlation between age (years) and IGF-1 concentration (pg/mL) in Alb-PRF samples measured using ELISA.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

Effect of Type 2 Diabetes on Insulin Like Growth Factor-1, Epidermal Growth Factor and Interleukin-6 Levels in Albumin Platelet-Rich Fibrin Membranes

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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