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Not yet recruiting NCT07518433

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

— Observational Diabetic Peripheral Neuropathy (DPN) Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Not applicable- observational study.
Who it may be relevant to
Registry conditions: Diabetic Peripheral Neuropathy (DPN), Pain. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Not applicable- observational study
    Not applicable- observational study

Primary outcome measures

  • Biospecimen Collection [Time frame: from month 0 to month 14]
Secondary outcome measures (12)
  • Toronto Clinical Scoring System [Time frame: from month 0 to month 14]
  • Neurological Physical Examination [Time frame: from month 0 to month 14]
  • Michigan Neuropathy Screening Instrument (MNSI) [Time frame: from month 0 to month 14]
  • Brief Pain Inventory for Diabetic Peripheral Neuropathy (BPI-DPN) [Time frame: from month 0 to month 14]
  • Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) [Time frame: from month 0 to month 14]
  • Neuropathic Pain 4 Questions (DN4) [Time frame: from month 0 to month 14]
  • Visual Analogue Scale (VAS) [Time frame: from month 0 to month 14]
  • Electrophysiological examination of the peroneal nerve of the lower limb [Time frame: from month 0 to month 14]
  • Electrophysiological examination of the tibial nerve of the lower limb [Time frame: from month 0 to month 14]
  • White Blood Cell Count (WBC) [Time frame: from month 0 to month 14]
  • Red Blood Cell Count (RBC) [Time frame: from month 0 to month 14]
  • Hemoglobin [Time frame: from month 0 to month 14]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou

Identifiers

NCT: NCT07518433 · 20251215064859996

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗