Diabetic Peripheral Neuropathy (DPN), Pain
Conditions
Keywords
Diabetic Peripheral Neuropathy, Pain
Brief summary
This part of the study enrolled 30 sex- and age-matched healthy controls, 30 diabetic patients without peripheral neuropathy, and 30 patients with diabetic peripheral neuropathy (DPN). Blood samples were collected from the participants, and serum was isolated for transcriptomics and untargeted metabolomics analysis using liquid chromatography-mass spectrometry (LC-MS) to characterize the metabolic profile of DPN. Through differential comparison analysis, serum biomarkers associated with DPN were identified and further correlated with clinical parameters. This approach aims to establish early diagnostic markers for DPN and provide scientific evidence for understanding the complex mechanisms underlying DPN, thereby offering new insights into potential therapeutic strategies.
Interventions
OTHERNot applicable- observational study
Not applicable- observational study
Sponsors
Zhejiang Chinese Medical University
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients diagnosed with diabetes mellitus (type 1 or type 2) * For the diabetic peripheral neuropathy (DPN) group: meet diagnostic criteria for painful diabetic peripheral neuropathy (P-DPN), defined as persistent pain and/or paresthesia in both lower limbs, with at least one objective sign of neuropathy (reduced ankle reflex, reduced vibration perception, or abnormal nerve conduction velocity when available), and a DN4 score ≥ 4 * For the diabetic control (DC) group: patients with diabetes mellitus but no evidence of peripheral neuropathy * For the healthy control (HC) group: healthy volunteers without diabetes or neuropathy, matched for sex and age * Aged between 18 and 80 years (inclusive) * Able to perform activities of daily living independently and cooperate with study procedures * No severe cardiac, cerebral, hepatic, renal, or other systemic diseases, and no severe mental illness or cognitive impairment * Willing to participate and provide written informed consent
Exclusion criteria
* Peripheral neuropathy caused by factors other than diabetes, including but not limited to hypothyroidism, alcohol abuse, medications, genetic disorders, or other systemic diseases * Presence of limb ulcers, gangrene, or a history of skin ulceration or non-healing wounds * Acute diabetic complications such as diabetic ketoacidosis, hyperosmolar hyperglycemic state, lactic acidosis, or severe infections within the past 3 months * Severe hepatic or renal impairment, or severe cardiovascular or cerebrovascular diseases (e.g., unstable angina, myocardial infarction, multiple cerebral infarctions, cerebral hemorrhage) * Scars or hyperpigmentation at the testing site that may interfere with accurate measurements * Pregnancy, breastfeeding, or planned pregnancy during the study period * Participation in another interventional clinical trial within 3 months prior to screening * For the diabetic control (DC) group: presence of peripheral neuropathy * For the healthy control (HC) group: history of diabetes mellitus, peripheral neuropathy, or use of medications affecting neurological function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biospecimen Collection | from month 0 to month 14 | Serum: 10 mL of fasting venous blood is collected using serum separation tubes. After resting and centrifugation, the serum is aliquoted into multiple tubes (500 μL per tube) and immediately stored in a -80°C ultra-low temperature freezer. Plasma and PAXgene tube whole blood are also collected for potential future multi-omics(such as serum transcriptomics and serum metabolomics) analyses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toronto Clinical Scoring System | from month 0 to month 14 | Total score ranges from 0 to 19 points, comprising symptom score (0-6, 0=absent, 1=present), reflex score (0-8, 0=normal, 1=reduced, 2=absent), and sensory score (0-5, 0=normal, 1=abnormal). Higher scores indicate greater severity of neuropathy. |
| Neurological Physical Examination | from month 0 to month 14 | Physical examination findings for neurological function assessment, including ankle reflex, vibration sense, pressure sense, pinprick pain sensation, and temperature sensation. Each sign is assessed and recorded as normal or abnormal. The presence and pattern of abnormalities are used to characterize the severity and distribution of neuropathy. |
| Michigan Neuropathy Screening Instrument (MNSI) | from month 0 to month 14 | Screening tool for assessing the severity of diabetic neuropathy, consisting of a patient-reported questionnaire and a physical examination component.The physical examination component yields a total score ranging from 0 to 8 points, which is the sum of 8 individual items. Higher scores indicate greater severity of peripheral neuropathy. The questionnaire component has a higher number of "yes" responses suggesting a higher likelihood of peripheral neuropathy. The two components are used together to assess the presence and severity of peripheral neuropathy. |
| Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN) | from month 0 to month 14 | Patient-reported outcome measure specifically designed to assess the impact of pain caused by diabetic peripheral neuropathy on daily life and mood.This scale focuses on the "interference" dimension of pain. Higher scores indicate greater impact of pain on quality of life. |
| Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) | from month 0 to month 14 | Assessment tool for distinguishing neuropathic pain from nociceptive pain, consisting of a pain questionnaire and sensory testing. Total score ranges from 0 to 24 points, derived from 7 items. Each item is scored based on "yes" responses with weighted values (5, 5, 3, 2, 1, 5, 3) or 0 for "no". A total score of 12 or higher indicates that neuropathic mechanisms are likely to be contributing to the patient's pain. |
| Neuropathic Pain 4 Questions (DN4) | from month 0 to month 14 | Screening tool for neuropathic pain consisting of 7 self-reported sensory items and 3 clinical examination items.Total score ranges from 0 to 10 points across 10 items. A total score of 4 or higher indicates the presence of neuropathic pain. |
| Visual Analogue Scale (VAS) | from month 0 to month 14 | Scale for assessing pain intensity at the affected site. Score ranges from 0 to 10 points, where 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, and 10 = worst possible pain. Higher scores indicate greater pain intensity. |
| Electrophysiological examination of the peroneal nerve of the lower limb | from month 0 to month 14 | The latency, amplitude, motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the peroneal nerve of the lower extremities were measured. |
| Electrophysiological examination of the tibial nerve of the lower limb | from month 0 to month 14 | The latency, amplitude, motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the tibial nerve of the lower extremities were measured by electrophysiological examination before and after treatment. |
| White Blood Cell Count (WBC) | from month 0 to month 14 | Laboratory test for safety monitoring.White blood cells: ×10⁹/L. |
| Red Blood Cell Count (RBC) | from month 0 to month 14 | Laboratory test for safety monitoring, measuring cellular components of the blood.Red blood cells: ×10¹²/L. |
| Hemoglobin | from month 0 to month 14 | Laboratory test for safety monitoring, measuring cellular components of the blood.Hemoglobin: g/L. |
| Platelet Count (PLT) | from month 0 to month 14 | Laboratory test for safety monitoring, measuring cellular components of the blood.Platelet Count: ×10⁹/L |
| Urinalysis Dipstick Test | from month 0 to month 14 | Dipstick testing for chemical constituents of urine. Categorical (normal/abnormal) |
| Urinalysis Microscopic Examination | from month 0 to month 14 | Microscopic examination of urine sediment. Results are reported as normal or abnormal. Abnormal findings (e.g., red blood cells, white blood cells, casts) are recorded as adverse events as applicable. |
| Fecal Occult Blood Test | from month 0 to month 14 | Laboratory test for safety monitoring to detect occult blood in stool. Results are reported as positive or negative. Positive findings are recorded as adverse events as applicable. |
| Alanine Aminotransferase (ALT) | from month 0 to month 14 | Laboratory tests for safety monitoring, including alanine aminotransferase (ALT): U/L. |
| Aspartate Aminotransferase (AST) | from month 0 to month 14 | Laboratory tests for safety monitoring, aspartate aminotransferase (AST): U/L. |
| Total Bilirubin (TBil) | from month 0 to month 14 | Laboratory tests for safety monitoring. Total bilirubin: μmol/L or mg/dL. |
| Serum Creatinine | from month 0 to month 14 | Laboratory tests for safety monitoring. Serum creatinine: μmol/L or mg/dL. |
| Blood Urea Nitrogen (BUN) | from month 0 to month 14 | Laboratory tests for safety monitoring. Blood urea nitrogen: mmol/L or mg/dL. |
Countries
China
Contacts
CONTACTYongliang Jiang
CONTACTJingjing Zhang
Outcome results
None listed