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NCT07518433

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

Sponsor: Zhejiang Chinese Medical University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-03-20

Completion Date

2027-06-30

Last Updated

2026-04-08

Healthy Volunteers

Yes

Conditions

Diabetic Peripheral Neuropathy (DPN)Pain

Interventions

OTHER

Not applicable- observational study

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

Locations (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China