Ultrasonographic Evaluation of Diabetic Neuropathy

Completed

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Other: Ultrasonographic evaluation of nerves in diabetic patients; Other: Ultrasonographic evaluation of nerves of healthy volunteers

• Registration Number: NCT02308059
• Lead Sponsor: Cukurova University

Brief Summary

The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with clinical and demographic data.

Detailed Description

Patients with diabetic peripheral neuropathy (n=53) and a matched healthy control group (n=53) underwent blinded ultrasonography imaging of the sciatic, tibial and median nerves. Matching was performed according to patient body mass index (BMI), sex and age. CSAs of the nerves were recorded, and the associations between pain intensity (measured with a visual analog scale \[VAS\]), the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, diabetes mellitus duration, BMI, HbA1c and blood glucose levels were evaluated.

Study Timeline

• Study Start: 2012-04
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-02
• Last Update Submitted: 2014-12-02
• Study First Posted: 2014-12-04
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• type 2 diabetes mellitus
• Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scores ≥ 12
• probable diabetic peripheral neuropathy according to the diabetic peripheral neuropathy criteria.

Exclusion Criteria

• type 1 diabetes mellitus
• hypothyroidism
• LANSS pain scale scores < 12
• body mass index (BMI) > 35
• current pregnancy
• histories of hereditary neuropathy, inflammatory neuropathy, nerve trauma, or other known causes of polyneuropathy; and the use of anti-neuropathic drugs.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with diabetes mellitus	Ultrasonographic evaluation of nerves in diabetic patients	Group I; the patients with diabetes mellitus who had peripheral neuropathy as diagnosed.
Control	Ultrasonographic evaluation of nerves of healthy volunteers	Group II; healthy volunteers

Primary Outcome Measures

Name	Time	Method
Pain scores on the visual analog scale	3 years

Secondary Outcome Measures

Name	Time	Method
Neuropathic pain scores on the Leeds Assessment of Neuropathic Symptoms and Signs pain scale	3 years