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Ultrasound Assessment of Sciatic Nerve and Inferior Gluteal Artery in Diabetic Peripheral Neuropathy(DPN): Association With a Target Gene

12 giugno 2026 aggiornato da: Zheng Guo, Second Hospital of Shanxi Medical University

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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:

  1. Demographic and Clinical Data Collection: Records include age, sex, body mass index, diabetes duration, HbA1c, and lipid profile.
  2. 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.
  3. Serum Biomarker Detection: Venous blood samples will be collected and centrifuged. Serum levels of the target protein MMP9 will be quantified.
  4. 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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

120

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Jiezheng Zhao
  • Numero di telefono: +86 19803416691
  • Email: sdfzjz01@163.com

Luoghi di studio

  • Cina
    • Shanxi
      • Taiyuan, Shanxi, Cina, 030001
        • Second Hospital of Shanxi Medical University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
TCSS Grade 1
Type 2 diabetes patients with TCSS score 0-5, indicating no or minimal neuropathy signs.
Altro: 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.
TCSS Grade 2
Type 2 diabetes patients with TCSS score 6-9, indicating moderate neuropathy.
Altro: 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.
TCSS Grade 3
Type 2 diabetes patients with TCSS score ≥ 10, indicating severe neuropathy.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Correlation Between Serum MMP9 Levels and Combined Ultrasonographic Parameters in Discriminating DPN Severity
Lasso di tempo: 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).
At the time of enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Differences in Sciatic Nerve Cross-Sectional Area Across DPN Severity Grades
Lasso di tempo: At the time of enrollment
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.
At the time of enrollment
Differences in Inferior Gluteal Artery Blood Flow Velocity Across DPN Severity Grades
Lasso di tempo: At the time of enrollment
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.
At the time of enrollment
Comparison of Nerve Conduction Study Parameters Across DPN Severity Grades
Lasso di tempo: At the time of enrollment
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.
At the time of enrollment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Second Hospital of Shanxi Medical University

Investigatori

  • Direttore dello studio: Yi Han, PhD, Second Hospital of Shanxi Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 maggio 2026

Completamento primario (Stimato)

10 luglio 2026

Completamento dello studio (Stimato)

20 luglio 2026

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HanYi20260511

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su No intervention (observational study)

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