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

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 Overview

• Status: Not yet recruiting
• Conditions: Pain; Diabetic Peripheral Neuropathy (DPN)
• Intervention / Treatment: Other: Not applicable- observational study

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Yongliang Jiang; Phone Number: 13858173136; Email: jyl2182@126.com
• Study Contact Backup: Name: Jingjing Zhang; Phone Number: 13277233394; Email: zjj1490@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310053
      • The Third Affiliated hospital of Zhejiang Chinese Medical University
      • Contact: Yongliang Jiang; Phone Number: 13858173136; Email: jyl2182@126.com
      • Principal Investigator: Yongliang Jiang
      • Sub-Investigator: Jingjing Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HC group; Sex- and age-matched healthy volunteers.	Other: Not applicable- observational study; Not applicable- observational study
DC group; Diabetic patients without neuropathy.	Other: Not applicable- observational study; Not applicable- observational study
DPN group; Patients with painful diabetic peripheral neuropathy.	Other: Not applicable- observational study; Not applicable- observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Diabetic Peripheral Neuropathy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 20251215064859996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No