An observational study in Polyneuropathies, Diabetic Complications Neurological and Diabetes Mellitus Type 2, sponsored by GÜLDEN ANATACA. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by GÜLDEN ANATACA · Observational
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.
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.
133 studies on the registry are indexed under Polyneuropathies; 33 are open to participants now.
This study's planned enrollment of 81 is below the median of 100 across 53 observational studies indexed under Polyneuropathies.
Browse Polyneuropathies studies →GÜLDEN ANATACA is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with Type 2 Diabetes Mellitus and diabetic polyneuropathy confirmed by clinical and electrophysiological evaluation.
Patients diagnosed with Type 2 Diabetes Mellitus without evidence of diabetic polyneuropathy.
Participants without diabetes mellitus or neuropathy.
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..
Time frame: Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Correlation Between Serum Irisin Concentration and Clinical Parameters
Correlation analyses will be performed to evaluate the relationship between serum irisin concentration and metabolic and clinical parameters, including: * Glycated hemoglobin (HbA1c) * Fasting plasma glucose * Body mass index (BMI) * Total cholesterol * LDL cholesterol * HDL cholesterol * Triglycerides * Duration of diabetes Presence of diabetic polyneuropathy confirmed by electrophysiological examination Correlation coefficients will be calculated using Pearson or Spearman correlation analysis depending on data distribution.
Time frame: Baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Start is estimated for Jul 2026; primary completion for Jul 2026, 0 months later.
Of 26 observational studies under Polyneuropathies, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 93. This study's planned 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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