Study on Serum Transcriptomics and Metabolomics in Patients With Diabetic Peripheral Neuropathy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorZhejiang Chinese Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not applicable- observational study
Other interventionNot applicable- observational study
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: HC group1 intervention
Group B: DC group1 intervention
Group C: DPN group1 intervention
Trial outcomes
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.
Time frame
from month 0 to month 14Secondary outcomes
1
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.
Time frame
from month 0 to month 142
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.
Time frame
from month 0 to month 143
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.
Time frame
from month 0 to month 144
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.
Time frame
from month 0 to month 14Sponsors and contacts
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Source ClinicalTrials.gov
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