Study on Serum Transcriptomics and Metabolomics in Patients With Diabetic Peripheral Neuropathy

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.

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.

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.

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.

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.

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.

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.

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.

The latency, amplitude, motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the peroneal nerve of the lower extremities were measured.

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.

Laboratory test for safety monitoring.White blood cells: ×10⁹/L.

Laboratory test for safety monitoring, measuring cellular components of the blood.Red blood cells: ×10¹²/L.

Laboratory test for safety monitoring, measuring cellular components of the blood.Hemoglobin: g/L.

Laboratory test for safety monitoring, measuring cellular components of the blood.Platelet Count: ×10⁹/L

Dipstick testing for chemical constituents of urine. Categorical (normal/abnormal)

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.

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.

Laboratory tests for safety monitoring, including alanine aminotransferase (ALT): U/L.

Laboratory tests for safety monitoring, aspartate aminotransferase (AST): U/L.

Laboratory tests for safety monitoring. Total bilirubin: μmol/L or mg/dL.

Laboratory tests for safety monitoring. Serum creatinine: μmol/L or mg/dL.

Laboratory tests for safety monitoring. Blood urea nitrogen: mmol/L or mg/dL.