Effects of Glycemic Control and Clinical Parameters on Tibial Nerve Conduction Latency in Diabetic Peripheral Neuropathy

NCT07525882 | Recruiting

• 1 other identifier: FBUni
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This observational cross-sectional study aims to investigate the effects of glycemic control and clinical parameters on tibial nerve conduction latency in individuals with diabetic peripheral neuropathy. Adults aged 45 to 76 years with diabetic peripheral neuropathy will be evaluated at a neurology and clinical neurophysiology clinic. Data collection will include demographic and clinical characteristics, diabetes type and duration, fasting blood glucose, and HbA1c values obtained from routine clinical records. Participants will also be assessed using the Michigan Neuropathy Screening Instrument (MNSI), including both the questionnaire and physical examination components. Nerve conduction studies will be performed using standard electromyography procedures, and tibial nerve conduction latency will be recorded. The study will examine the relationship between tibial nerve conduction latency and glycemic control parameters, neuropathy screening scores, and diabetes duration. The findings may help improve early identification and clinical evaluation of diabetic peripheral neuropathy.

Conditions

Diabetes Mellitus; Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy; Tibial Nerve Conduction Latency; Glycemic Control; Electromyography; Nerve Conduction Study

Outcome Measures

Primary Outcomes (6)

• Tibial Nerve Conduction Latency

  Tibial nerve conduction latency measured by standard nerve conduction study/electromyography procedures in individuals with diabetic peripheral neuropathy. The study will evaluate its relationship with glycemic control parameters, Michigan Neuropathy Screening Instrument scores, and diabetes duration.

  At baseline

• Michigan Neuropathy Screening Instrument Questionnaire Score

  The Michigan Neuropathy Screening Instrument (MNSI) Questionnaire is a participant-reported measure used to assess neuropathic symptoms in individuals with diabetic peripheral neuropathy. The questionnaire consists of 15 yes/no items. Responses are scored according to the standard MNSI scoring approach, and the total score is calculated by summing the scored items. In this study, a score of 4 or higher will be interpreted as indicating neuropathic symptom involvement. Higher scores indicate a greater burden of neuropathic symptoms, whereas lower scores indicate fewer reported neuropathic symptoms. The questionnaire score will be analyzed in relation to tibial nerve conduction latency.

  At baseline

• Michigan Neuropathy Screening Instrument Examination Score

  The Michigan Neuropathy Screening Instrument (MNSI) Examination is a researcher-administered clinical assessment used to evaluate signs of diabetic peripheral neuropathy. The examination includes assessment of vibration sensation, ankle reflexes, and the presence of foot ulceration or deformity. Each examination component is scored according to predefined criteria, and the total score is calculated on an 8-point scale. In this study, a total score of 2.5 or higher will be considered abnormal. Higher scores indicate more severe clinical findings consistent with peripheral neuropathy, whereas lower scores indicate fewer abnormal examination findings. The examination score will be analyzed in relation to tibial nerve conduction latency.

  At baseline

• Hemoglobin A1c (HbA1c)

  HbA1c value obtained from routine clinical laboratory records as an indicator of glycemic control.

  At baseline

• Fasting Blood Glucose

  Fasting blood glucose value obtained from routine clinical laboratory records.

  At baseline

• Diabetes Duration

  Duration of diabetes recorded from clinical history and patient records.

  At baseline

Study Arms (1)

Individuals With Diabetic Peripheral Neuropathy

Adults aged 45 to 76 years with diabetic peripheral neuropathy diagnosed based on laboratory findings, clinical findings, and nerve conduction test results. Participants will undergo collection of demographic and clinical data, assessment with the Michigan Neuropathy Screening Instrument, and nerve conduction studies including tibial nerve conduction latency measurement.

Eligibility Criteria

• Age: 45 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 45 to 76 years with diabetic peripheral neuropathy who present to the Uzm. Dr. Gaye Yildirim Neurology and Clinical Neurophysiology Clinic and meet the eligibility criteria. Participants will have diabetes-related neuropathy diagnosed based on laboratory tests, clinical findings, and nerve conduction test results. Individuals with major neurological, systemic, infectious, oncological, renal, hepatic, or substance-related conditions that may affect peripheral nerve function will be excluded.

You may qualify if:

• Participants aged 45 to 76 years
• Diagnosis of diabetes-related neuropathy based on laboratory tests, clinical findings, and nerve conduction test (NCT) results

You may not qualify if:

• History of autoimmune disease, cerebrovascular disease, or chronic infectious disease
• Diagnosis of cancer or a history of chemotherapy and/or radiotherapy
• Radicular neuropathy
• Chronic kidney failure or liver failure
• Alcoholism or other substance dependence
• Mental or physical disability (including blindness)
• Inability to speak Turkish

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Fenerbahçe University

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Sümeyye Akçay, Asst. Prof.

CONTACT

+905424002553; smyye.akcy@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)