PolyneuropathiesNCT07734597
Is Serum Irisin Level a Biomarker in Diabetic Polyneuropathy?
An observational study of Polyneuropathies and Diabetic Complications Neurological, run by GÜLDEN ANATACA at 1 site in Turkey (Türkiye).
Trial summary
Diabetic polyneuropathy is a common complication of type 2 diabetes mellitus associated with sensory impairment and functional disability. Irisin is a myokine that has been implicated in glucose metabolism and neuroprotection. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyneuropathies, Diabetic Complications Neurological, Diabetes Mellitus Type 2
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2026to 30 Sep 2026
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult participants aged between 30 and 75 years who are followed at the Internal Medicine outpatient clinic of Kanuni Sultan Süleyman Training and Research Hospital between jul, 2026 and semptember, 2026. A total of 81 participants will be enrolled and categorized into three groups according to clinical and electrophysiological evaluation findings: Group 1 (DPN+): Patients with Type 2 Diabetes Mellitus and confirmed diabetic polyneuropathy Group 2 (DPN-): Patients with Type 2 Diabetes Mellitus without evidence of diabetic polyneuropathy Group 3 (Healthy Controls): Individuals without diabetes mellitus or neuropathy Participants will be enrolled regardless of sex. Eligible participants must be capable of understanding and signing the informed consent form. Patients with neuropathy due to non-diabetic causes, chronic kidney disease, active infection, neuromuscular disorders, central nervous system diseases, or severe orthopedic conditions affectin
Who may be able to join
- Age between 30 and 75 years
- Diagnosis of Type 2 Diabetes Mellitus for at least 1 year (for diabetic groups)
- Ability to understand and sign informed consent
- Willingness to participate in the study
Who cannot join
- Neuropathy due to causes other than diabetes (e.g., vitamin B12 deficiency, chronic alcohol use, chemotherapy-induced neuropathy)
- Chronic kidney disease (eGFR <60 mL/min/1.73 m²)
- Active infection
- Myopathies or other muscle diseases
- Central nervous system diseases (e.g., stroke, Parkinson disease)
- Severe orthopedic conditions impairing mobility
- Inability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul
gülden ANATACA, +905059284244, ganataca@yahoo.com
About this study
Official title: Evaluation of Serum Irisin Levels as a Potential Biomarker in Patients With Diabetic Polyneuropathy: A Single-center Prospective Cross-sectional Observational Study
Diabetic polyneuropathy is a common complication of type 2 diabetes mellitus associated with sensory impairment and functional disability. Irisin is a myokine that has been implicated in glucose metabolism and neuroprotection. This prospective observational case-control study aims to evaluate serum irisin concentrations in patients with diabetic polyneuropathy compared with diabetic patients without neuropathy and healthy controls, and to investigate whether serum irisin may serve as a biomarker for diabetic polyneuropathy.
Read the detailed description
Diabetes Mellitus is characterized by insulin resistance and/or relative insulin deficiency and is associated with several microvascular complications. Diabetic peripheral polyneuropathy is among the most common and disabling complications, leading to sensory loss, proprioceptive impairment, postural instability, gait abnormalities, and increased fall risk.
Irisin, a myokine released from skeletal muscle during physical activity, has emerged as an important regulator of systemic metabolism. Reduced irisin levels have been associated with insulin resistance, chronic inflammation, mitochondrial dysfunction, and skeletal muscle atrophy, all of which may contribute to the progression of diabetic neuropathy.
Although previous studies have separately investigated diabetic neuropathy and serum irisin levels, limited data exist regarding their direct relationship. Therefore, this study was designed to evaluate serum irisin levels in patients with diabetic polyneuropathy from a holistic perspective and to investigate its potential role as a biomarker.
- Keywords
- Biomarker, Type 2 Diabetes Mellitus, Diabetic polyneuropathies, Serum Irisin
- Medical subject headings
- Polyneuropathies, Diabetes Mellitus, Type 2, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: DPN+ | Patients diagnosed with Type 2 Diabetes Mellitus and diabetic polyneuropathy confirmed by clinical and electrophysiological evaluation. | |
| Group 2: DPN- | Patients diagnosed with Type 2 Diabetes Mellitus without evidence of diabetic polyneuropathy. | |
| Group 3: Healthy Control | Participants without diabetes mellitus or neuropathy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Irisin Concentration
Serum irisin concentration (ng/mL) will be measured from fasting venous blood samples using a commercially available enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions. Serum irisin concentrations will be compared among participants with diabetic polyneuropathy (DPN+), participants with Type 2 Diabetes Mellitus without diabetic polyneuropathy (DPN-), and healthy control participants. The primary objective is to evaluate whether serum irisin concentration may serve as a biomarker for diabetic polyneuropathy..
Measured: Baseline
Secondary outcomes (4)
Glycated Hemoglobin (HbA1c) Concentration
Glycated hemoglobin (HbA1c) concentration (%) will be measured using standardized high-performance liquid chromatography (HPLC) methods in the hospital biochemistry laboratory. HbA1c levels will be compared among study groups and analyzed for their relationship with serum irisin concentration.
Measured: Baseline
Fasting Plasma Glucose
Fasting plasma glucose concentration (mg/dL) will be measured after an overnight fast using routine biochemical laboratory methods. Fasting glucose levels will be compared among study groups and evaluated for their association with serum irisin concentration.
Measured: Baseline
Body Mass Index (BMI)
Body mass index (kg/m²) will be calculated by dividing body weight in kilograms by the square of height in meters (kg/m²). BMI values will be compared among the three study groups and analyzed for their association with serum irisin concentration.
Measured: Baseline
Presence of Diabetic Polyneuropathy Confirmed by Electrophysiological Examination
Diabetic polyneuropathy will be diagnosed using standardized neurological examination and nerve conduction studies (electromyography, EMG) according to predefined diagnostic criteria described in the study protocol.
This outcome is not based on a numerical rating scale. Participants will be classified into one of the following categories:
- Diabetic polyneuropathy present (DPN+)
- Diabetic polyneuropathy absent (DPN-)
The presence or absence of diabetic polyneuropathy will be used for comparison with serum irisin concentration and other metabolic variables.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PolyneuropathiesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- GÜLDEN ANATACA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, GÜLDEN ANATACA, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734597
- Sponsor's protocol ID
- KAEK/2026.05.190
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Callaghan BC, Cheng HT, Stables CL, Smith AL, Feldman EL. Diabetic neuropathy: clinical manifestations and current treatments. Lancet Neurol. 2012 Jun;11(6):521-34. doi: 10.1016/S1474-4422(12)70065-0. Epub 2012 May 16.
PubMed 22608666Colaianni G, Cuscito C, Mongelli T, Oranger A, Mori G, Brunetti G, Colucci S, Cinti S, Grano M. Irisin enhances osteoblast differentiation in vitro. Int J Endocrinol. 2014;2014:902186. doi: 10.1155/2014/902186. Epub 2014 Mar 4.
PubMed 24723951Hicks CW, Selvin E. Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes. Curr Diab Rep. 2019 Aug 27;19(10):86. doi: 10.1007/s11892-019-1212-8.
PubMed 31456118Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.
PubMed 20876709
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Irisin Levels as a Potential Biomarker in Patients With Diabetic Polyneuropathy: A Single-center Prospective Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT07734597
- Acronym / sponsor ID
- KAEK/2026.05.190
- Keywords
- Biomarker, Type 2 Diabetes Mellitus, Diabetic polyneuropathies, Serum Irisin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- GÜLDEN ANATACAUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Jul 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.
Diabetic polyneuropathy is a common complication of type 2 diabetes mellitus associated with sensory impairment and functional disability. Irisin is a myokine that has been implicated in glucose metabolism and neuroprotection. This prospective observational case-control study aims to evaluate serum irisin concentrations in patients with diabetic polyneuropathy compared with diabetic patients without neuropathy and healthy controls, and to investigate whether serum irisin may serve as a biomarker for diabetic polyneuropathy.
Detailed description
Diabetes Mellitus is characterized by insulin resistance and/or relative insulin deficiency and is associated with several microvascular complications. Diabetic peripheral polyneuropathy is among the most common and disabling complications, leading to sensory loss, proprioceptive impairment, postural instability, gait abnormalities, and increased fall risk.
Irisin, a myokine released from skeletal muscle during physical activity, has emerged as an important regulator of systemic metabolism. Reduced irisin levels have been associated with insulin resistance, chronic inflammation, mitochondrial dysfunction, and skeletal muscle atrophy, all of which may contribute to the progression of diabetic neuropathy.
Although previous studies have separately investigated diabetic neuropathy and serum irisin levels, limited data exist regarding their direct relationship. Therefore, this study was designed to evaluate serum irisin levels in patients with diabetic polyneuropathy from a holistic perspective and to investigate its potential role as a biomarker.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: DPN+ | – | –Patients diagnosed with Type 2 Diabetes Mellitus and diabetic polyneuropathy confirmed by clinical and electrophysiological evaluation. |
| Group 2: DPN- | – | –Patients diagnosed with Type 2 Diabetes Mellitus without evidence of diabetic polyneuropathy. |
| Group 3: Healthy Control | – | –Participants without diabetes mellitus or neuropathy. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult participants aged between 30 and 75 years who are followed at the Internal Medicine outpatient clinic of Kanuni Sultan Süleyman Training and Research Hospital between jul, 2026 and semptember, 2026. A total of 81 participants will be enrolled and categorized into three groups according to clinical and electrophysiological evaluation findings: Group 1 (DPN+): Patients with Type 2 Diabetes Mellitus and confirmed diabetic polyneuropathy Group 2 (DPN-): Patients with Type 2 Diabetes Mellitus without evidence of diabetic polyneuropathy Group 3 (Healthy Controls): Individuals without diabetes mellitus or neuropathy Participants will be enrolled regardless of sex. Eligible participants must be capable of understanding and signing the informed consent form. Patients with neuropathy due to non-diabetic causes, chronic kidney disease, active infection, neuromuscular disorders, central nervous system diseases, or severe orthopedic conditions affectin
Key inclusion criteria (4 listed)
- Age between 30 and 75 years
- Diagnosis of Type 2 Diabetes Mellitus for at least 1 year (for diabetic groups)
- Ability to understand and sign informed consent
- Willingness to participate in the study
Key exclusion criteria (7 listed)
- Neuropathy due to causes other than diabetes (e.g., vitamin B12 deficiency, chronic alcohol use, chemotherapy-induced neuropathy)
- Chronic kidney disease (eGFR <60 mL/min/1.73 m²)
- Active infection
- Myopathies or other muscle diseases
- Central nervous system diseases (e.g., stroke, Parkinson disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Irisin Concentration
Time frame: Baseline
Serum irisin concentration (ng/mL) will be measured from fasting venous blood samples using a commercially available enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions. Serum irisin concentrations will be compared among participants with diabetic polyneuropathy (DPN+), participants with Type 2 Diabetes Mellitus without diabetic polyneuropathy (DPN-), and healthy control participants. The primary objective is to evaluate whether serum irisin concentration may serve as a biomarker for diabetic polyneuropathy..
4 secondary outcomes
Glycated Hemoglobin (HbA1c) Concentration
Time frame: Baseline
Fasting Plasma Glucose
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Presence of Diabetic Polyneuropathy Confirmed by Electrophysiological Examination
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 22608666Callaghan BC, Cheng HT, Stables CL, Smith AL, Feldman EL. Diabetic neuropathy: clinical manifestations and current treatments. Lancet Neurol. 2012 Jun;11(6):521-34. doi: 10.1016/S1474-4422(12)70065-0. Epub 2012 May 16.
- Background: PubMed 24723951Colaianni G, Cuscito C, Mongelli T, Oranger A, Mori G, Brunetti G, Colucci S, Cinti S, Grano M. Irisin enhances osteoblast differentiation in vitro. Int J Endocrinol. 2014;2014:902186. doi: 10.1155/2014/902186. Epub 2014 Mar 4.
- Background: PubMed 31456118Hicks CW, Selvin E. Epidemiology of Peripheral Neuropathy and Lower Extremity Disease in Diabetes. Curr Diab Rep. 2019 Aug 27;19(10):86. doi: 10.1007/s11892-019-1212-8.
- Results publication: PubMed 20876709Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyneuropathies and Diabetic Complications Neurological, run by GÜLDEN ANATACA 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gülden ANATACA (+905059284244, ganataca@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Irisin Concentration (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07734597, which also lists 4 linked publications.
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 29 Jul 2026.