Diabetic PolyneuropathyNCT06514846
Utilizing the Michigan Neuropathy Screening Instrument for Early Detection of Diabetic Neuropathy
An observational study of Diabetic Polyneuropathy, run by Sohag University at 1 site in Egypt.
Trial summary
The study aims to Compare the diagnostic accuracy of the Michigan Neuropathy Screening Instrument (MNSI) (using MNS questionnaire, ,Inspection, vibratory sensation, Ankle reflexes Exam, 10 g monofilament needle examination), routine NCS, and the U/S of the median, posterior tibial, and sural nerves in identifying… Read more about this study
- Who is it for?
- Ages 33 to 65 years
- Conditions the study is for
- Diabetic Polyneuropathy
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 33 to 65 years
- All sexes
- Adult, Older adult
Study population: Place of study: Participants will be recruited from the diabetes clinic, Sohag university hospital. * Type of the study: Cross-Sectional Comparative study. * Patients: v Study group: participants of the study will meet the following criteria: Ø Inclusion criteria: ü Age: 30-55 y ü Type of diabetes: Type 2 ü Duration of diabetes: Within 1Year of diagnosis of Type 2 diabetes mellitus according to World Health Organization 1999 criteria ü Gender: Both males \& females Ø Exclusion criteria: Patients who had known conditions that could present with neuropathy such as hereditary sensory neuropathy, vitamin B12 or folate deficiency, paraneoplastic conditions, autoimmune diseases, uremia, hypothyroidism, and ethanol abuse.
Who may be able to join
- ü Age: 30-55 y
- ü Type of diabetes: Type 2
- ü Duration of diabetes: Within 1Year of diagnosis of Type 2 diabetes mellitus according to World Health Organization 1999 criteria
Who cannot join
- Patients who had known conditions that could present with neuropathy such as hereditary sensory neuropathy, vitamin B12 or folate deficiency, paraneoplastic conditions, autoimmune diseases, uremia, hypothyroidism, and ethanol abuse.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medecine Sohag university
Sohag
Reda Khalil, Resident, 0102 006 5913, redakhalaf@med.sohag.edu.eg
About this study
Official title: Utilizing the Michigan Neuropathy Screening Instrument, Routine Nerve Conduction Study (NCS), and Nerve Ultrasound for Early Detection of Diabetic Neuropathy
The study aims to Compare the diagnostic accuracy of the Michigan Neuropathy Screening Instrument (MNSI) (using MNS questionnaire, ,Inspection, vibratory sensation, Ankle reflexes Exam, 10 g monofilament needle examination), routine NCS, and the U/S of the median, posterior tibial, and sural nerves in identifying diabetic peripheral neuropathy in patients recently diagnosed with type 2 diabetes.
- Conditions
- Diabetic Polyneuropathy
- Medical subject headings
- Diabetic Neuropathies
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 |
|---|---|---|
| Patients Group | Study Population: Place of study: Participants will be recruited from the diabetes clinic, Sohag university hospital. Type of the study: Cross-Sectional Comparative study. Patients: v Study group: participants of the study will meet the following criteria: Ø Inclusion criteria: ü Age: 30-55 y ü Type of diabetes: Type 2 ü Duration of diabetes: Within 1 Year of diagnosis of Type 2 diabetes mellitus according to World Health Organization 1999 criteria ü Gender: Both males \& females Ø Exclusion criteria: Patients who had known conditions that could present with neuropathy such as hereditary sensory neuropathy, vitamin B12 or folate deficiency, paraneoplastic conditions, autoimmune diseases, uremia, hypothyroidism, and ethanol abuse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of Diabetic Neuropathy
Utilizing the Michigan Neuropathy Screening Instrument, routine nerve conduction study, and nerve ultrasound for early detection of Diabetic Neuropathy
Measured: Searching in patients diagnosed within 1 year or less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jun 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reda Khalafallah Khalil, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514846
- Sponsor's protocol ID
- Soh-Med-24-06-01MS
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing the Michigan Neuropathy Screening Instrument, Routine Nerve Conduction Study (NCS), and Nerve Ultrasound for Early Detection of Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT06514846
- Acronym / sponsor ID
- Soh-Med-24-06-01MS
- Conditions
- Diabetic Polyneuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 23 Jul 2024 (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.
The study aims to Compare the diagnostic accuracy of the Michigan Neuropathy Screening Instrument (MNSI) (using MNS questionnaire, ,Inspection, vibratory sensation, Ankle reflexes Exam, 10 g monofilament needle examination), routine NCS, and the U/S of the median, posterior tibial, and sural nerves in identifying diabetic peripheral neuropathy in patients recently diagnosed with type 2 diabetes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Group | – | –Study Population: Place of study: Participants will be recruited from the diabetes clinic, Sohag university hospital. Type of the study: Cross-Sectional Comparative study. Patients: v Study group: participants of the study will meet the following criteria: Ø Inclusion criteria: ü Age: 30-55 y ü Type of diabetes: Type 2 ü Duration of diabetes: Within 1 Year of diagnosis of Type 2 diabetes mellitus according to World Health Organization 1999 criteria ü Gender: Both males \& females Ø Exclusion criteria: Patients who had known conditions that could present with neuropathy such as hereditary sensory neuropathy, vitamin B12 or folate deficiency, paraneoplastic conditions, autoimmune diseases, uremia, hypothyroidism, and ethanol abuse. |
Who may qualify
- Ages
- 33 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Place of study: Participants will be recruited from the diabetes clinic, Sohag university hospital. * Type of the study: Cross-Sectional Comparative study. * Patients: v Study group: participants of the study will meet the following criteria: Ø Inclusion criteria: ü Age: 30-55 y ü Type of diabetes: Type 2 ü Duration of diabetes: Within 1Year of diagnosis of Type 2 diabetes mellitus according to World Health Organization 1999 criteria ü Gender: Both males \& females Ø Exclusion criteria: Patients who had known conditions that could present with neuropathy such as hereditary sensory neuropathy, vitamin B12 or folate deficiency, paraneoplastic conditions, autoimmune diseases, uremia, hypothyroidism, and ethanol abuse.
Key inclusion criteria (3 listed)
- ü Age: 30-55 y
- ü Type of diabetes: Type 2
- ü Duration of diabetes: Within 1Year of diagnosis of Type 2 diabetes mellitus according to World Health Organization 1999 criteria
Key exclusion criteria (1 listed)
- Patients who had known conditions that could present with neuropathy such as hereditary sensory neuropathy, vitamin B12 or folate deficiency, paraneoplastic conditions, autoimmune diseases, uremia, hypothyroidism, and ethanol abuse.
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
Early detection of Diabetic Neuropathy
Time frame: Searching in patients diagnosed within 1 year or less
Utilizing the Michigan Neuropathy Screening Instrument, routine nerve conduction study, and nerve ultrasound for early detection of Diabetic Neuropathy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Polyneuropathy, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reda Khalaf Allah Khalil, Resident (0102 006 5913, redakhalaf@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detection of Diabetic Neuropathy (time frame: Searching in patients diagnosed within 1 year or less). 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 30 Jul 2024.