Healthy ParticipantsNCT07672652
Effect of Type 2 Diabetes on Biomarker Levels in Albumin Platelet-Rich Fibrin
A study testing Venous blood sampling and Alb-PRF preparation in people with Healthy Participants and Diabetes Mellitus (Type 2), run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Diabetes Mellitus (Type 2)
- What is being tested?
- Venous blood sampling and Alb-PRF preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Katip Çelebi University
Izmir, Cigli, 35620
About this study
Official 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
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.
Read more
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.
- Conditions
- Healthy Participants, Diabetes Mellitus (Type 2)
- Being tested
- Venous blood sampling and Alb-PRF preparation
- Keywords
- Alb-PRF, Diabetes Mellitus, Epidermal Growth Factor, Insulin Like Growth Factor-1, Interleukin-6, EGF, IGF-1, IL-6, Albumin Platelet Rich Fibrin
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood sampling and Alb-PRF preparationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes Group | Experimental | 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. Receives: Procedure: Venous blood sampling and Alb-PRF preparation |
| Systemically Healthy Group | Experimental | 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. Receives: Procedure: Venous blood sampling and Alb-PRF preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 Levels in Alb-PRF samples
Interleukin-6 (IL-6) levels will be measured in Alb-PRF samples obtained from participants using ELISA.
Measured: Baseline (Day 1)
EGF level in Alb-PRF samples
Epidermal growth factor (EGF) levels will be measured in Alb-PRF samples obtained from participants using ELISA.
Measured: Baseline (Day 1)
IGF-1 level in Alb-PRF samples
Insulin-like growth factor-1 (IGF-1) levels will be measured in Alb-PRF samples obtained from participants using ELISA.
Measured: Baseline (Day 1)
Secondary outcomes (3)
Correlation between age and IL-6 concentration in Alb-PRF samples
Correlation between age (years) and IL-6 concentration (pg/mL) in Alb-PRF samples measured using ELISA.
Measured: Baseline (Day 1)
Correlation between age and EGF concentration in Alb-PRF samples
Correlation between age (years) and EGF concentration (pg/mL) in Alb-PRF samples measured using ELISA.
Measured: Baseline (Day 1)
Correlation between age and IGF-1 concentration in Alb-PRF samples
Correlation between age (years) and IGF-1 concentration (pg/mL) in Alb-PRF samples measured using ELISA.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start15 Dec 2025
- Primary completion20 Mar 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Gizem Altıntaş, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672652
- Sponsor's protocol ID
- 2025-SAEK-0034
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07672652
- Acronym / sponsor ID
- 2025-SAEK-0034
- Conditions
- Healthy Participants, Diabetes Mellitus (Type 2)
- Keywords
- Alb-PRF, Diabetes Mellitus, Epidermal Growth Factor, Insulin Like Growth Factor-1, Interleukin-6, EGF, IGF-1, IL-6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Group | Experimental | Procedure: Venous blood sampling and Alb-PRF preparationParticipants 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. |
| Systemically Healthy Group | Experimental | Procedure: Venous blood sampling and Alb-PRF preparationSystemically 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous blood sampling and Alb-PRF preparationVenous 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. | Procedure or surgery | Systemically Healthy Group, Type 2 Diabetes Group |
Primary outcome
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.
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.
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.
3 secondary outcomes
Correlation between age and IL-6 concentration in Alb-PRF samples
Time frame: Baseline (Day 1)
Correlation between age and EGF concentration in Alb-PRF samples
Time frame: Baseline (Day 1)
Correlation between age and IGF-1 concentration in Alb-PRF samples
Time frame: Baseline (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous blood sampling and Alb-PRF preparation in people with Healthy Participants and Diabetes Mellitus (Type 2), run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 Levels in Alb-PRF samples (time frame: Baseline (Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.