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

April 6, 2026 updated by: Yongliang Jiang, Zhejiang Chinese Medical University
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310053
        • The Third Affiliated hospital of Zhejiang Chinese Medical University
        • Contact:
        • Principal Investigator:
          • Yongliang Jiang
        • Sub-Investigator:
          • Jingjing Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biospecimen Collection
Time Frame: from month 0 to month 14
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Toronto Clinical Scoring System
Time Frame: from month 0 to month 14
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
Time Frame: from month 0 to month 14
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)
Time Frame: from month 0 to month 14
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)
Time Frame: from month 0 to month 14
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)
Time Frame: from month 0 to month 14
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)
Time Frame: from month 0 to month 14
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)
Time Frame: from month 0 to month 14
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
Time Frame: from month 0 to month 14
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
Time Frame: from month 0 to month 14
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)
Time Frame: from month 0 to month 14
Laboratory test for safety monitoring.White blood cells: ×10⁹/L.
from month 0 to month 14
Red Blood Cell Count (RBC)
Time Frame: from month 0 to month 14
Laboratory test for safety monitoring, measuring cellular components of the blood.Red blood cells: ×10¹²/L.
from month 0 to month 14
Hemoglobin
Time Frame: from month 0 to month 14
Laboratory test for safety monitoring, measuring cellular components of the blood.Hemoglobin: g/L.
from month 0 to month 14
Platelet Count (PLT)
Time Frame: from month 0 to month 14
Laboratory test for safety monitoring, measuring cellular components of the blood.Platelet Count: ×10⁹/L
from month 0 to month 14
Urinalysis Dipstick Test
Time Frame: from month 0 to month 14
Dipstick testing for chemical constituents of urine. Categorical (normal/abnormal)
from month 0 to month 14
Urinalysis Microscopic Examination
Time Frame: from month 0 to month 14
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
Time Frame: from month 0 to month 14
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)
Time Frame: from month 0 to month 14
Laboratory tests for safety monitoring, including alanine aminotransferase (ALT): U/L.
from month 0 to month 14
Aspartate Aminotransferase (AST)
Time Frame: from month 0 to month 14
Laboratory tests for safety monitoring, aspartate aminotransferase (AST): U/L.
from month 0 to month 14
Total Bilirubin (TBil)
Time Frame: from month 0 to month 14
Laboratory tests for safety monitoring. Total bilirubin: μmol/L or mg/dL.
from month 0 to month 14
Serum Creatinine
Time Frame: from month 0 to month 14
Laboratory tests for safety monitoring. Serum creatinine: μmol/L or mg/dL.
from month 0 to month 14
Blood Urea Nitrogen (BUN)
Time Frame: from month 0 to month 14
Laboratory tests for safety monitoring. Blood urea nitrogen: mmol/L or mg/dL.
from month 0 to month 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings