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.
Study Type
OBSERVATIONAL
Enrollment
90
Not applicable- observational study
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
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.
Time frame: from month 0 to month 14
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.
Time frame: from month 0 to month 14
Neurological Physical Examination
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: from month 0 to month 14
White Blood Cell Count (WBC)
Laboratory test for safety monitoring.White blood cells: ×10⁹/L.
Time frame: 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.
Time frame: from month 0 to month 14
Hemoglobin
Laboratory test for safety monitoring, measuring cellular components of the blood.Hemoglobin: g/L.
Time frame: from month 0 to month 14
Platelet Count (PLT)
Laboratory test for safety monitoring, measuring cellular components of the blood.Platelet Count: ×10⁹/L
Time frame: from month 0 to month 14
Urinalysis Dipstick Test
Dipstick testing for chemical constituents of urine. Categorical (normal/abnormal)
Time frame: 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.
Time frame: 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.
Time frame: from month 0 to month 14
Alanine Aminotransferase (ALT)
Laboratory tests for safety monitoring, including alanine aminotransferase (ALT): U/L.
Time frame: from month 0 to month 14
Aspartate Aminotransferase (AST)
Laboratory tests for safety monitoring, aspartate aminotransferase (AST): U/L.
Time frame: from month 0 to month 14
Total Bilirubin (TBil)
Laboratory tests for safety monitoring. Total bilirubin: μmol/L or mg/dL.
Time frame: from month 0 to month 14
Serum Creatinine
Laboratory tests for safety monitoring. Serum creatinine: μmol/L or mg/dL.
Time frame: from month 0 to month 14
Blood Urea Nitrogen (BUN)
Laboratory tests for safety monitoring. Blood urea nitrogen: mmol/L or mg/dL.
Time frame: from month 0 to month 14
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