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.
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.
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)
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.
Other
Cross-sectional
No intervention (observational study)
Other interventionThis 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.
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).
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.
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.
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.
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