Utilizing the Michigan Neuropathy Screening Instrument for Early Detection of Diabetic Neuropathy

July 27, 2024 updated by: Reda Khalafallah Khalil, Sohag University

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Faculty of medecine Sohag university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

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.

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Searching in patients diagnosed within 1 year or less

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 27, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-06-01MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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