Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HC group | Sex- and age-matched healthy volunteers. |
| |
| DC group | Diabetic patients without neuropathy. |
| |
| DPN group | Patients with painful diabetic peripheral neuropathy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable- observational study | Other | Not applicable- observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biospecimen Collection | 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. | from month 0 to month 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Clinical Scoring System | 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. | from month 0 to month 14 |
| Neurological Physical Examination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
This study will enroll three groups of participants: (1) patients with painful diabetic peripheral neuropathy (P-DPN) meeting defined diagnostic criteria, (2) diabetic patients without peripheral neuropathy, and (3) healthy volunteers without diabetes or neuropathy, matched for sex and age.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongliang Jiang | Contact | 13858173136 | jyl2182@126.com | |
| Jingjing Zhang | Contact | 13277233394 | zjj1490@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Zhejiang Chinese Medical University | Hangzhou | Zhejiang | 310053 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| from month 0 to month 14 |
| Michigan Neuropathy Screening Instrument (MNSI) | 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. | from month 0 to month 14 |
| Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN) | 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. | from month 0 to month 14 |
| Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) | 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. | from month 0 to month 14 |
| Neuropathic Pain 4 Questions (DN4) | 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. | from month 0 to month 14 |
| Visual Analogue Scale (VAS) | 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. | from month 0 to month 14 |
| Electrophysiological examination of the peroneal nerve of the lower limb | The latency, amplitude, motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the peroneal nerve of the lower extremities were measured. | from month 0 to month 14 |
| Electrophysiological examination of the tibial nerve of the lower limb | 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. | from month 0 to month 14 |
| White Blood Cell Count (WBC) | Laboratory test for safety monitoring.White blood cells: ×10⁹/L. | from month 0 to month 14 |
| Red Blood Cell Count (RBC) | Laboratory test for safety monitoring, measuring cellular components of the blood.Red blood cells: ×10¹²/L. | from month 0 to month 14 |
| Hemoglobin | Laboratory test for safety monitoring, measuring cellular components of the blood.Hemoglobin: g/L. | from month 0 to month 14 |
| Platelet Count (PLT) | Laboratory test for safety monitoring, measuring cellular components of the blood.Platelet Count: ×10⁹/L | from month 0 to month 14 |
| Urinalysis Dipstick Test | Dipstick testing for chemical constituents of urine. Categorical (normal/abnormal) | from month 0 to month 14 |
| Urinalysis Microscopic Examination | 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. | from month 0 to month 14 |
| Fecal Occult Blood Test | 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. | from month 0 to month 14 |
| Alanine Aminotransferase (ALT) | Laboratory tests for safety monitoring, including alanine aminotransferase (ALT): U/L. | from month 0 to month 14 |
| Aspartate Aminotransferase (AST) | Laboratory tests for safety monitoring, aspartate aminotransferase (AST): U/L. | from month 0 to month 14 |
| Total Bilirubin (TBil) | Laboratory tests for safety monitoring. Total bilirubin: μmol/L or mg/dL. | from month 0 to month 14 |
| Serum Creatinine | Laboratory tests for safety monitoring. Serum creatinine: μmol/L or mg/dL. | from month 0 to month 14 |
| Blood Urea Nitrogen (BUN) | Laboratory tests for safety monitoring. Blood urea nitrogen: mmol/L or mg/dL. | from month 0 to month 14 |