Diabetic Peripheral Neuropathy (DPN)NCT07518433
Study on Serum Transcriptomics and Metabolomics in Patients With Diabetic Peripheral Neuropathy
An observational study of Diabetic Peripheral Neuropathy (DPN) and Pain, run by Zhejiang Chinese Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN), Pain
- What is being tested?
- Not applicable- observational study
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 30 Jun 2027
- How long will I take part?
- 90 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310053
Yongliang Jiang, 13858173136, jyl2182@126.com
Yongliang Jiang
About this study
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
- Being tested
- Not applicable- observational study
- Keywords
- Diabetic Peripheral Neuropathy, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
| Study group | Role | What they receive |
|---|---|---|
| HC group | Sex- and age-matched healthy volunteers. Receives: Other: Not applicable- observational study | |
| DC group | Diabetic patients without neuropathy. Receives: Other: Not applicable- observational study | |
| DPN group | Patients with painful diabetic peripheral neuropathy. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from month 0 to month 14
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: from month 0 to month 14
White Blood Cell Count (WBC)
Laboratory test for safety monitoring.White blood cells: ×10⁹/L.
Measured: 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.
Measured: from month 0 to month 14
Hemoglobin
Laboratory test for safety monitoring, measuring cellular components of the blood.Hemoglobin: g/L.
Measured: from month 0 to month 14
Platelet Count (PLT)
Laboratory test for safety monitoring, measuring cellular components of the blood.Platelet Count: ×10⁹/L
Measured: from month 0 to month 14
Urinalysis Dipstick Test
Dipstick testing for chemical constituents of urine. Categorical (normal/abnormal)
Measured: 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.
Measured: 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.
Measured: from month 0 to month 14
Alanine Aminotransferase (ALT)
Laboratory tests for safety monitoring, including alanine aminotransferase (ALT): U/L.
Measured: from month 0 to month 14
Aspartate Aminotransferase (AST)
Laboratory tests for safety monitoring, aspartate aminotransferase (AST): U/L.
Measured: from month 0 to month 14
Total Bilirubin (TBil)
Laboratory tests for safety monitoring. Total bilirubin: μmol/L or mg/dL.
Measured: from month 0 to month 14
Serum Creatinine
Laboratory tests for safety monitoring. Serum creatinine: μmol/L or mg/dL.
Measured: from month 0 to month 14
Blood Urea Nitrogen (BUN)
Laboratory tests for safety monitoring. Blood urea nitrogen: mmol/L or mg/dL.
Measured: from month 0 to month 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 Mar 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 90 participants (estimated)
- Target duration
- 90 Months
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yongliang Jiang, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518433
- Sponsor's protocol ID
- 20251215064859996
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Serum Transcriptomics and Metabolomics in Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07518433
- Acronym / sponsor ID
- 20251215064859996
- Conditions
- Diabetic Peripheral Neuropathy (DPN), Pain
- Keywords
- Diabetic Peripheral Neuropathy, Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhejiang Chinese Medical UniversityOther government
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 90 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HC group | – | Other: Not applicable- observational studySex- and age-matched healthy volunteers. |
| DC group | – | Other: Not applicable- observational studyDiabetic patients without neuropathy. |
| DPN group | – | Other: Not applicable- observational studyPatients with painful diabetic peripheral neuropathy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | DC group, DPN group, HC group |
Primary outcome
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.
21 secondary outcomes
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
Platelet Count (PLT)
Time frame: from month 0 to month 14
Urinalysis Dipstick Test
Time frame: from month 0 to month 14
Urinalysis Microscopic Examination
Time frame: from month 0 to month 14
Fecal Occult Blood Test
Time frame: from month 0 to month 14
Alanine Aminotransferase (ALT)
Time frame: from month 0 to month 14
Aspartate Aminotransferase (AST)
Time frame: from month 0 to month 14
Total Bilirubin (TBil)
Time frame: from month 0 to month 14
Serum Creatinine
Time frame: from month 0 to month 14
Blood Urea Nitrogen (BUN)
Time frame: from month 0 to month 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathy (DPN) and Pain, run by Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongliang Jiang (13858173136, jyl2182@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biospecimen Collection (time frame: from month 0 to month 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.