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

June 27, 2026 updated by: Aylin Gizem Altıntaş, Izmir Katip Celebi University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Cigli
      • Izmir, Cigli, Turkey (Türkiye), 35620
        • Izmir Katip Celebi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Venous 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.
Experimental: 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.
Procedure: Venous 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1)
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.
Baseline (Day 1)
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.
Baseline (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1)
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.
Baseline (Day 1)
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.
Baseline (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Actual)

March 20, 2026

Study Completion (Actual)

June 15, 2026

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 27, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-SAEK-0034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy and ethical restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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