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

NCT07518433 | Not Yet Recruiting

• 1 other identifier: 20251215064859996
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy (DPN); Pain

Keywords

Diabetic Peripheral Neuropathy; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Toronto Clinical Scoring System

  from month 0 to month 14

• Neurological Physical Examination

  from month 0 to month 14

• Michigan Neuropathy Screening Instrument (MNSI)

  from month 0 to month 14

• Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN)

  from month 0 to month 14

• Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)

  from month 0 to month 14

Study Arms (3)

HC group

Sex- and age-matched healthy volunteers.

Other: Not applicable- observational study

DC group

Diabetic patients without neuropathy.

Other: Not applicable- observational study

DPN group

Patients with painful diabetic peripheral neuropathy.

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

DC group; DPN group; HC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. 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. 2. Urine 3. Faeces

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yongliang Jiang

CONTACT

13858173136; jyl2182@126.com

Jingjing Zhang

CONTACT

13277233394; zjj1490@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 90 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 8, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)