Diabetic Peripheral Neuropathy (DPN)NCT07595887
Ultrasound Assessment of Sciatic Nerve and Inferior Gluteal Artery in Diabetic Peripheral Neuropathy(DPN): Association With a Target Gene
An observational study of Diabetic Peripheral Neuropathy (DPN), run by Second Hospital of Shanxi Medical University at 1 site in China.
Trial summary
Diabetic peripheral neuropathy (DPN) is a common and serious complication of diabetes that causes numbness, pain, and weakness, often starting in the feet. Currently, there is no cure, and early diagnosis is difficult with standard tests alone. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 20 Jul 2026
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will recruit 120 adult male and female patients diagnosed with type 2 diabetes mellitus from the Endocrinology Department of the Second Hospital of Shanxi Medical University. All participants will be stratified into groups based on diabetic peripheral neuropathy (DPN) severity assessed by the Toronto Clinical Scoring System (TCSS). Participants will include patients across the full spectrum of DPN severity, ranging from those with no or minimal neuropathy signs to those with severe clinically evident neuropathy. The study does not include a healthy non-diabetic control group. Participants will undergo a single-visit assessment including high-frequency ultrasound of the sciatic nerve and inferior gluteal artery, nerve conduction studies, and blood sample collection for serum biomarker analysis.
Who may be able to join
- Patients diagnosed with type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria; Aged between 20 and 75 years; Willing to provide written informed consent; Ability to comply with all study assessments including ultrasound examination, nerve conduction studies, and blood sampling.
Who cannot join
- Peripheral neuropathy caused by non-diabetic conditions, including severe hepatic or renal disease, nutritional deficiencies, connective tissue diseases, or other metabolic or hereditary disorders; Nerve root compression due to cervical spondylosis or lumbar disc herniation; History of chronic alcohol abuse or long-term exposure to toxic substances (e.g., heavy metals) that may cause peripheral nerve damage; History of medication use known to affect peripheral nerve function (e.g., isoniazid, furazolidone)
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
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Zheng Guo, M.B., Ph.D., +863513365790, guozheng713@yahoo.com
About this study
Official title: An Observational Study to Explore the Early Diagnostic Value of Ultrasonographic Sciatic Nerve Cross-Sectional Area and Inferior Gluteal Artery Blood Flow Velocity in Patients With Diabetic Peripheral Neuropathy Stratified by Severity: Integrating Bioinformatics-Based Exploration of Neuropathy Mechanisms and Correlation With a DPN Target Gene
Diabetic peripheral neuropathy (DPN) is a common and serious complication of diabetes that causes numbness, pain, and weakness, often starting in the feet. Currently, there is no cure, and early diagnosis is difficult with standard tests alone. This observational study aims to find better ways to detect DPN in its early stages.
The researchers will use high-frequency ultrasound, a painless and non-invasive imaging tool, to measure two things in patients with type 2 diabetes: the cross-sectional area of the sciatic nerve (to look for swelling) and the blood flow velocity in the inferior gluteal artery (a vessel that supplies the nerve).In parallel, a bioinformatics analysis has identified a key target gene, Matrix Metalloproteinase 9(MMP9), which may play a role in nerve damage through a specific signaling pathway. The level of this protein will be measured in the patients' blood.
A total of 120 participants will be grouped by the severity of their nerve damage, assessed by Toronto Clinical Scoring System (TCSS). The study will investigate whether the ultrasound measurements correlate with the clinical scores, nerve conduction studies, and the blood levels of the target protein. The ultimate goal is to combine these ultrasound structure, blood flow function, and molecular markers to build a more accurate tool for the early diagnosis and precise management of DPN, bridging the gap from early warning to mechanism-based care.
Read the detailed description
This study is a prospective, observational, cross-sectional investigation designed to explore the early diagnostic value of high-frequency ultrasound in patients with type 2 diabetic peripheral neuropathy(DPN) by integrating bioinformatics-derived molecular markers. The study aims to validate a "Structure-function-molecule" cascade hypothesis for DPN progression.
Background and Rationale:
DPN is a highly disabling complication of diabetes with no current disease-modifying treatment, underscoring the urgent need for early detection. Prior work by our group found that elevated N/OFQ in DPN rats was associated with reduced limb blood flow, mediated by Membrane Metallo-Endopeptidase(MME). Shifting the focus from vascular to neural mechanisms, the present study employed independent bioinformatics analysis and identified MMP9 as a core target gene linking N/OFQ to DPN-related nerve damage, enriched in the AMPK signaling pathway. This clinical study therefore aims to validate MMP9 as a serum biomarker and examine its correlation with sciatic nerve cross-sectional area and inferior gluteal artery blood flow velocity on ultrasound across DPN severity grades.
Study Design and Participants:
A total of 120 adult patients with type 2 diabetes mellitus, diagnosed according to World Health Organization criteria, will be consecutively recruited from the Endocrinology Department of the Second Hospital of Shanxi Medical University.
Grouping and Assessments:
Participants will be stratified into three distinct severity grades based on the Toronto Clinical Scoring System(TCSS): Grade 1 (0-5 points), Grade 2 (6-9 points), Grade 3 (≥10 points). Each participant will undergo the following integrated assessments:
- Demographic and Clinical Data Collection: Records include age, sex, body mass index, diabetes duration, HbA1c, and lipid profile.
- Ultrasound Examination: With the patient in a lateral decubitus position (hip and knee flexed), a high-frequency linear probe will be placed at the midpoint between the ischial tuberosity and the greater trochanter to visualize the sciatic nerve. Color and pulsed-wave Doppler will subsequently measure blood flow velocity in the inferior gluteal artery.
- Serum Biomarker Detection: Venous blood samples will be collected and centrifuged. Serum levels of the target protein MMP9 will be quantified.
- Nerve Conduction Studies:
Standard electrophysiological parameters, including motor nerve conduction velocity(MNCV) and sensory nerve conduction velocity(SNCV) for the lower limbs, will be recorded for correlation.
Outcome Measures and Statistical Analysis:
Statistical analysis will employ ANOVA or Kruskal-Wallis tests for inter-group comparisons. Pearson or Spearman correlation coefficients will quantify the relationships among nerve structure, blood flow, and molecular markers. The combined diagnostic performance will be assessed using receiver operating characteristic (ROC) curves and logistic regression models to calculate the area under the curve (AUC). The study hypothesizes that a multimodal diagnostic model integrating imaging and serum biomarkers will provide superior sensitivity and specificity for early DPN detection compared to single-modality assessments alone.
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Being tested
- No intervention (observational study)
- Keywords
- Diabetic Peripheral Neuropathy, Type 2 Diabetes, High-Frequency Ultrasound, Sciatic Nerve Cross-Sectional Area, Inferior Gluteal Artery Blood Flow, Matrix Metalloproteinase 9 (MMP9), Nociceptin/Orphanin FQ (N/OFQ), Toronto Clinical Scoring System (TCSS), AMPK Signaling Pathway, Early Diagnosis, Observational Study
- Medical subject headings
- Diabetes Mellitus, Type 2, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
This is a purely observational study. No investigational drug, device, or biological product will be administered, and no clinical procedures will be performed outside of standard clinical care for the sole purpose of this research. All participants will receive routine standard-of-care as determined by their treating physicians. The study will only involve non-invasive data collection including clinical assessment, ultrasound imaging, nerve conduction studies, and blood sampling for biomarker analysis, which are all conducted as part of the study assessments, not as interventions.
| Study group | Role | What they receive |
|---|---|---|
| TCSS Grade 1 | Type 2 diabetes patients with TCSS score 0-5, indicating no or minimal neuropathy signs. Receives: Other: No intervention (observational study) | |
| TCSS Grade 2 | Type 2 diabetes patients with TCSS score 6-9, indicating moderate neuropathy. Receives: Other: No intervention (observational study) | |
| TCSS Grade 3 | Type 2 diabetes patients with TCSS score ≥ 10, indicating severe neuropathy. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Serum MMP9 Levels and Combined Ultrasonographic Parameters in Discriminating DPN Severity
The combined diagnostic performance of the multimodal (ultrasound + serum biomarker) for early DPN detection will be assessed using receiver operating characteristic (ROC) curve analysis and expressed as the area under the curve (AUC).
Measured: At the time of enrollment
Secondary outcomes (3)
Differences in Sciatic Nerve Cross-Sectional Area Across DPN Severity Grades
To compare the sciatic nerve cross-sectional area (CSA, in mm²) measured by high-frequency ultrasound among groups with different DPN severity grades defined by TCSS scores.
Measured: At the time of enrollment
Differences in Inferior Gluteal Artery Blood Flow Velocity Across DPN Severity Grades
To compare the peak systolic velocity (PSV) of the inferior gluteal artery measured by pulsed-wave Doppler ultrasound among groups with different DPN severity grades.
Measured: At the time of enrollment
Comparison of Nerve Conduction Study Parameters Across DPN Severity Grades
To compare motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of bilateral common peroneal, tibial sural, and superficial peroneal nerves among groups with different DPN severity grades.
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start20 May 2026 (estimated)
- Primary completion10 Jul 2026 (estimated)
- Study completion20 Jul 2026 (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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
- Investigators
- Yi Han, PhD, Study director, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595887
- Sponsor's protocol ID
- HanYi20260511
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single-center, investigator-initiated observational study conducted as part of a postgraduate thesis. Individual participant data will not be shared due to institutional data privacy regulations and the absence of a dedicated data-sharing infrastructure. Requests for summary-level results may be considered upon reasonable inquiry to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Explore the Early Diagnostic Value of Ultrasonographic Sciatic Nerve Cross-Sectional Area and Inferior Gluteal Artery Blood Flow Velocity in Patients With Diabetic Peripheral Neuropathy Stratified by Severity: Integrating Bioinformatics-Based Exploration of Neuropathy Mechanisms and Correlation With a DPN Target Gene
- ClinicalTrials.gov ID
- NCT07595887
- Acronym / sponsor ID
- HanYi20260511
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Keywords
- Diabetic Peripheral Neuropathy, Type 2 Diabetes, High-Frequency Ultrasound, Sciatic Nerve Cross-Sectional Area, Inferior Gluteal Artery Blood Flow, Matrix Metalloproteinase 9 (MMP9), Nociceptin/Orphanin FQ (N/OFQ), Toronto Clinical Scoring System (TCSS)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 19 May 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.
Diabetic peripheral neuropathy (DPN) is a common and serious complication of diabetes that causes numbness, pain, and weakness, often starting in the feet. Currently, there is no cure, and early diagnosis is difficult with standard tests alone. This observational study aims to find better ways to detect DPN in its early stages.
The researchers will use high-frequency ultrasound, a painless and non-invasive imaging tool, to measure two things in patients with type 2 diabetes: the cross-sectional area of the sciatic nerve (to look for swelling) and the blood flow velocity in the inferior gluteal artery (a vessel that supplies the nerve).In parallel, a bioinformatics analysis has identified a key target gene, Matrix Metalloproteinase 9(MMP9), which may play a role in nerve damage through a specific signaling pathway. The level of this protein will be measured in the patients' blood.
A total of 120 participants will be grouped by the severity of their nerve damage, assessed by Toronto Clinical Scoring System (TCSS). The study will investigate whether the ultrasound measurements correlate with the clinical scores, nerve conduction studies, and the blood levels of the target protein. The ultimate goal is to combine these ultrasound structure, blood flow function, and molecular markers to build a more accurate tool for the early diagnosis and precise management of DPN, bridging the gap from early warning to mechanism-based care.
Detailed description
This study is a prospective, observational, cross-sectional investigation designed to explore the early diagnostic value of high-frequency ultrasound in patients with type 2 diabetic peripheral neuropathy(DPN) by integrating bioinformatics-derived molecular markers. The study aims to validate a "Structure-function-molecule" cascade hypothesis for DPN progression.
Background and Rationale:
DPN is a highly disabling complication of diabetes with no current disease-modifying treatment, underscoring the urgent need for early detection. Prior work by our group found that elevated N/OFQ in DPN rats was associated with reduced limb blood flow, mediated by Membrane Metallo-Endopeptidase(MME). Shifting the focus from vascular to neural mechanisms, the present study employed independent bioinformatics analysis and identified MMP9 as a core target gene linking N/OFQ to DPN-related nerve damage, enriched in the AMPK signaling pathway. This clinical study therefore aims to validate MMP9 as a serum biomarker and examine its correlation with sciatic nerve cross-sectional area and inferior gluteal artery blood flow velocity on ultrasound across DPN severity grades.
Study Design and Participants:
A total of 120 adult patients with type 2 diabetes mellitus, diagnosed according to World Health Organization criteria, will be consecutively recruited from the Endocrinology Department of the Second Hospital of Shanxi Medical University.
Grouping and Assessments:
Participants will be stratified into three distinct severity grades based on the Toronto Clinical Scoring System(TCSS): Grade 1 (0-5 points), Grade 2 (6-9 points), Grade 3 (≥10 points). Each participant will undergo the following integrated assessments:
- Demographic and Clinical Data Collection: Records include age, sex, body mass index, diabetes duration, HbA1c, and lipid profile.
- Ultrasound Examination: With the patient in a lateral decubitus position (hip and knee flexed), a high-frequency linear probe will be placed at the midpoint between the ischial tuberosity and the greater trochanter to visualize the sciatic nerve. Color and pulsed-wave Doppler will subsequently measure blood flow velocity in the inferior gluteal artery.
- Serum Biomarker Detection: Venous blood samples will be collected and centrifuged. Serum levels of the target protein MMP9 will be quantified.
- Nerve Conduction Studies:
Standard electrophysiological parameters, including motor nerve conduction velocity(MNCV) and sensory nerve conduction velocity(SNCV) for the lower limbs, will be recorded for correlation.
Outcome Measures and Statistical Analysis:
Statistical analysis will employ ANOVA or Kruskal-Wallis tests for inter-group comparisons. Pearson or Spearman correlation coefficients will quantify the relationships among nerve structure, blood flow, and molecular markers. The combined diagnostic performance will be assessed using receiver operating characteristic (ROC) curves and logistic regression models to calculate the area under the curve (AUC). The study hypothesizes that a multimodal diagnostic model integrating imaging and serum biomarkers will provide superior sensitivity and specificity for early DPN detection compared to single-modality assessments alone.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TCSS Grade 1 | – | Other: No intervention (observational study)Type 2 diabetes patients with TCSS score 0-5, indicating no or minimal neuropathy signs. |
| TCSS Grade 2 | – | Other: No intervention (observational study)Type 2 diabetes patients with TCSS score 6-9, indicating moderate neuropathy. |
| TCSS Grade 3 | – | Other: No intervention (observational study)Type 2 diabetes patients with TCSS score ≥ 10, indicating severe neuropathy. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit 120 adult male and female patients diagnosed with type 2 diabetes mellitus from the Endocrinology Department of the Second Hospital of Shanxi Medical University. All participants will be stratified into groups based on diabetic peripheral neuropathy (DPN) severity assessed by the Toronto Clinical Scoring System (TCSS). Participants will include patients across the full spectrum of DPN severity, ranging from those with no or minimal neuropathy signs to those with severe clinically evident neuropathy. The study does not include a healthy non-diabetic control group. Participants will undergo a single-visit assessment including high-frequency ultrasound of the sciatic nerve and inferior gluteal artery, nerve conduction studies, and blood sample collection for serum biomarker analysis.
Key inclusion criteria (1 listed)
- Patients diagnosed with type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria; Aged between 20 and 75 years; Willing to provide written informed consent; Ability to comply with all study assessments including ultrasound examination, nerve conduction studies, and blood sampling.
Key exclusion criteria (1 listed)
- Peripheral neuropathy caused by non-diabetic conditions, including severe hepatic or renal disease, nutritional deficiencies, connective tissue diseases, or other metabolic or hereditary disorders; Nerve root compression due to cervical spondylosis or lumbar disc herniation; History of chronic alcohol abuse or long-term exposure to toxic substances (e.g., heavy metals) that may cause peripheral nerve damage; History of medication use known to affect peripheral nerve function (e.g., isoniazid, furazolidone)
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 |
|---|---|---|
| No intervention (observational study)This is a purely observational study. No investigational drug, device, or biological product will be administered, and no clinical procedures will be performed outside of standard clinical care for the sole purpose of this research. All participants will receive routine standard-of-care as determined by their treating physicians. The study will only involve non-invasive data collection including clinical assessment, ultrasound imaging, nerve conduction studies, and blood sampling for biomarker analysis, which are all conducted as part of the study assessments, not as interventions. | Other | TCSS Grade 1, TCSS Grade 2, TCSS Grade 3 |
Primary outcome
Correlation Between Serum MMP9 Levels and Combined Ultrasonographic Parameters in Discriminating DPN Severity
Time frame: At the time of enrollment
The combined diagnostic performance of the multimodal (ultrasound + serum biomarker) for early DPN detection will be assessed using receiver operating characteristic (ROC) curve analysis and expressed as the area under the curve (AUC).
3 secondary outcomes
Differences in Sciatic Nerve Cross-Sectional Area Across DPN Severity Grades
Time frame: At the time of enrollment
Differences in Inferior Gluteal Artery Blood Flow Velocity Across DPN Severity Grades
Time frame: At the time of enrollment
Comparison of Nerve Conduction Study Parameters Across DPN Severity Grades
Time frame: At the time of enrollment
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 16 Jun 2026.
- Individual participant dataSharing planned: No. This is a single-center, investigator-initiated observational study conducted as part of a postgraduate thesis. Individual participant data will not be shared due to institutional data privacy regulations and the absence of a dedicated data-sharing infrastructure. Requests for summary-level results may be considered upon reasonable inquiry to the principal investigator.
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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.
Yi Han, PhD study director
Second Hospital of Shanxi Medical University
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), run by Second Hospital of Shanxi 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 1 inclusion and 1 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 16 Jun 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 Jiezheng Zhao (+86 19803416691, sdfzjz01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Serum MMP9 Levels and Combined Ultrasonographic Parameters in Discriminating DPN Severity (time frame: At the time of enrollment). 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 16 Jun 2026.