Diabetic Peripheral NeuropathyNCT07525882
Effects of Glycemic Control and Clinical Parameters on Tibial Nerve Conduction Latency in Diabetic Peripheral Neuropathy
An observational study of Diabetic Peripheral Neuropathy and Diabetes Mellitus, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 76 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Diabetes Mellitus
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Apr 2026to Jun 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 45 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participants aged 45 to 76 years
- Diagnosis of diabetes-related neuropathy based on laboratory tests, clinical findings, and nerve conduction test (NCT) results
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Fenerbahçe University
Istanbul, Ataşehir, 34758
About this study
Official title: Investigation of the Effects of Glycemic Control and Clinical Parameters on Tibial Nerve Conduction Latency in Individuals With Diabetic Peripheral Neuropathy
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.
Read the detailed description
Diabetic peripheral neuropathy is one of the most common chronic complications of diabetes mellitus and is associated with sensory loss, pain, and sensorimotor impairment, particularly in the distal extremities. Persistent hyperglycemia may contribute to structural and functional damage in peripheral nerves through metabolic and microvascular mechanisms. Electrophysiological abnormalities such as prolonged latency and reduced conduction velocity are commonly observed in affected individuals. Tibial nerve conduction latency may provide clinically relevant information for the evaluation of diabetic peripheral neuropathy.
The aim of this observational, cross-sectional, analytical study is to investigate the effects of glycemic control parameters and clinical variables on tibial nerve conduction latency in individuals with diabetic peripheral neuropathy.
The study will be conducted at Uzm. Dr. Gaye Yildirim Neurology and Clinical Neurophysiology Clinic. Participants will include individuals aged 45 to 76 years with diabetic peripheral neuropathy diagnosed on the basis of laboratory findings, clinical findings, and nerve conduction test results. Individuals with autoimmune disease, cerebrovascular disease, chronic infectious disease, cancer, history of chemotherapy or radiotherapy, radicular neuropathy, chronic kidney failure, liver failure, alcoholism or substance dependence, mental or physical disability, or inability to speak Turkish will be excluded.
Data will be collected through face-to-face assessment, clinical evaluation, and review of routine clinical records. Demographic and clinical variables will include age, height, weight, education level, diabetes type, and diabetes duration. Glycemic control parameters will include fasting blood glucose and HbA1c values obtained from routine laboratory tests; no additional laboratory testing will be requested specifically for the study.
Neuropathy assessment will include the Michigan Neuropathy Screening Instrument (MNSI), consisting of both the questionnaire and physical examination components. The questionnaire will be completed by participants, and the examination component will be performed by the researcher. Clinical assessment will include vibration sensation, ankle reflexes, and the presence of foot ulceration or deformity.
Nerve conduction studies will be performed in the clinical neurophysiology laboratory using standard electromyography procedures. Motor and sensory conduction parameters of upper and lower extremity nerves will be evaluated, and tibial nerve conduction latency will be recorded as the main electrophysiological outcome. Peripheral neuropathy will be defined on the basis of abnormalities in at least two different nerves, including changes in conduction velocity, reduced amplitude, and/or prolonged F-wave latency.
The primary analysis will examine the relationship between tibial nerve conduction latency and fasting blood glucose, HbA1c, MNSI questionnaire score, MNSI examination score, and diabetes duration using multiple linear regression analysis. Descriptive statistics will be presented as mean, standard deviation, number, and percentage, and statistical significance will be set at p<0.05.
The planned sample size is at least 50 participants, based on an a priori power analysis for multiple linear regression. The study is expected to contribute to the early identification, risk evaluation, and clinical follow-up of diabetic peripheral neuropathy.
- Conditions
- Diabetic Peripheral Neuropathy, Diabetes Mellitus
- Keywords
- Diabetic Peripheral Neuropathy, Tibial Nerve Conduction Latency, Glycemic Control, Electromyography, Nerve Conduction Study
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline
Hemoglobin A1c (HbA1c)
HbA1c value obtained from routine clinical laboratory records as an indicator of glycemic control.
Measured: At baseline
Fasting Blood Glucose
Fasting blood glucose value obtained from routine clinical laboratory records.
Measured: At baseline
Diabetes Duration
Duration of diabetes recorded from clinical history and patient records.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start13 Apr 2026
- Primary completionJun 2026 (estimated)
- Study completionJun 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 NeuropathyStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye Akçay, Fenerbahce University
- Investigators
- Sümeyye Akçay, Asst. Prof., Principal investigator, Fenerbahçe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525882
- Sponsor's protocol ID
- FBUni
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes clinical and electrophysiological data collected from a limited patient population, and data sharing may create risks for participant confidentiality and privacy. Only de-identified aggregate results will be reported in scientific publications or presentations.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Glycemic Control and Clinical Parameters on Tibial Nerve Conduction Latency in Individuals With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07525882
- Acronym / sponsor ID
- FBUni
- Conditions
- Diabetic Peripheral Neuropathy, Diabetes Mellitus
- Keywords
- Diabetic Peripheral Neuropathy, Tibial Nerve Conduction Latency, Glycemic Control, Electromyography, Nerve Conduction Study
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Apr 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.
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.
Detailed description
Diabetic peripheral neuropathy is one of the most common chronic complications of diabetes mellitus and is associated with sensory loss, pain, and sensorimotor impairment, particularly in the distal extremities. Persistent hyperglycemia may contribute to structural and functional damage in peripheral nerves through metabolic and microvascular mechanisms. Electrophysiological abnormalities such as prolonged latency and reduced conduction velocity are commonly observed in affected individuals. Tibial nerve conduction latency may provide clinically relevant information for the evaluation of diabetic peripheral neuropathy.
The aim of this observational, cross-sectional, analytical study is to investigate the effects of glycemic control parameters and clinical variables on tibial nerve conduction latency in individuals with diabetic peripheral neuropathy.
The study will be conducted at Uzm. Dr. Gaye Yildirim Neurology and Clinical Neurophysiology Clinic. Participants will include individuals aged 45 to 76 years with diabetic peripheral neuropathy diagnosed on the basis of laboratory findings, clinical findings, and nerve conduction test results. Individuals with autoimmune disease, cerebrovascular disease, chronic infectious disease, cancer, history of chemotherapy or radiotherapy, radicular neuropathy, chronic kidney failure, liver failure, alcoholism or substance dependence, mental or physical disability, or inability to speak Turkish will be excluded.
Data will be collected through face-to-face assessment, clinical evaluation, and review of routine clinical records. Demographic and clinical variables will include age, height, weight, education level, diabetes type, and diabetes duration. Glycemic control parameters will include fasting blood glucose and HbA1c values obtained from routine laboratory tests; no additional laboratory testing will be requested specifically for the study.
Neuropathy assessment will include the Michigan Neuropathy Screening Instrument (MNSI), consisting of both the questionnaire and physical examination components. The questionnaire will be completed by participants, and the examination component will be performed by the researcher. Clinical assessment will include vibration sensation, ankle reflexes, and the presence of foot ulceration or deformity.
Nerve conduction studies will be performed in the clinical neurophysiology laboratory using standard electromyography procedures. Motor and sensory conduction parameters of upper and lower extremity nerves will be evaluated, and tibial nerve conduction latency will be recorded as the main electrophysiological outcome. Peripheral neuropathy will be defined on the basis of abnormalities in at least two different nerves, including changes in conduction velocity, reduced amplitude, and/or prolonged F-wave latency.
The primary analysis will examine the relationship between tibial nerve conduction latency and fasting blood glucose, HbA1c, MNSI questionnaire score, MNSI examination score, and diabetes duration using multiple linear regression analysis. Descriptive statistics will be presented as mean, standard deviation, number, and percentage, and statistical significance will be set at p<0.05.
The planned sample size is at least 50 participants, based on an a priori power analysis for multiple linear regression. The study is expected to contribute to the early identification, risk evaluation, and clinical follow-up of diabetic peripheral neuropathy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 45 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Participants aged 45 to 76 years
- Diagnosis of diabetes-related neuropathy based on laboratory tests, clinical findings, and nerve conduction test (NCT) results
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tibial Nerve Conduction Latency
Time frame: At baseline
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.
Michigan Neuropathy Screening Instrument Questionnaire Score
Time frame: At baseline
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.
Michigan Neuropathy Screening Instrument Examination Score
Time frame: At baseline
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.
Hemoglobin A1c (HbA1c)
Time frame: At baseline
HbA1c value obtained from routine clinical laboratory records as an indicator of glycemic control.
Fasting Blood Glucose
Time frame: At baseline
Fasting blood glucose value obtained from routine clinical laboratory records.
Diabetes Duration
Time frame: At baseline
Duration of diabetes recorded from clinical history and patient records.
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 23 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes clinical and electrophysiological data collected from a limited patient population, and data sharing may create risks for participant confidentiality and privacy. Only de-identified aggregate results will be reported in scientific publications or presentations.
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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.
Sümeyye Akçay, Asst. Prof. principal investigator
Fenerbahçe 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 and Diabetes Mellitus, run by Fenerbahce University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 23 Apr 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tibial Nerve Conduction Latency (time frame: At baseline). The study lists 6 primary outcomes in all. 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 23 Apr 2026.