Ultrasound Assessment of Sciatic Nerve and Inferior Gluteal Artery in DPN: Association With a Target Gene

NCT07595887 | Not Yet Recruiting

• 1 other identifier: HanYi20260511
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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, 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 a 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.

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); AMPK Signaling Pathway; Early Diagnosis; Observational Study

Outcome Measures

Primary Outcomes (1)

• 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).

  At the time of enrollment

Secondary Outcomes (3)

• Differences in Sciatic Nerve Cross-Sectional Area Across DPN Severity Grades

  At the time of enrollment

• Differences in Inferior Gluteal Artery Blood Flow Velocity Across DPN Severity Grades

  At the time of enrollment

• Comparison of Nerve Conduction Study Parameters Across DPN Severity Grades

  At the time of enrollment

Study Arms (3)

TCSS Grade 1

Type 2 diabetes patients with TCSS score 0-5, indicating no or minimal neuropathy signs.

Other: No intervention (observational study)

TCSS Grade 2

Type 2 diabetes patients with TCSS score 6-9, indicating moderate neuropathy.

Other: No intervention (observational study)

TCSS Grade 3

Type 2 diabetes patients with TCSS score ≥ 10, indicating severe neuropathy.

Other: No intervention (observational study)

Interventions

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.

TCSS Grade 1; TCSS Grade 2; TCSS Grade 3

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Second Hospital of Shanxi Medical University: lead

Study Sites (1)

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Yi Han, PhD

  Second Hospital of Shanxi Medical University

  STUDY DIRECTOR

Central Study Contacts

Jiezheng Zhao

CONTACT

+86 19803416691; sdfzjz01@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)