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

NCT06514846 | Recruiting

• 1 other identifier: Soh-Med-24-06-01MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 diabetic peripheral neuropathy in patients recently diagnosed with type 2 diabetes.

Conditions

Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• Early detection of Diabetic Neuropathy

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 33 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of medecine Sohag university

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Reda Khalaf Allah Khalil, Resident

CONTACT

0102 006 5913; redakhalaf@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

EG (1)