Ultrasonographic Evaluation of Diabetic Neuropathy

Diabetic Peripheral Neuropathy: Correlation Between Ultrasound Findings and Clinical Features

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Other: Ultrasonographic evaluation of nerves in diabetic patients; Other: Ultrasonographic evaluation of nerves of healthy volunteers

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 Type: Observational
• Enrollment (Actual): 106

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatients in a University Hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with diabetes mellitus; Group I; the patients with diabetes mellitus who had peripheral neuropathy as diagnosed.	Other: Ultrasonographic evaluation of nerves in diabetic patients; Ultrasonographic evaluation of peripheral nerves in patients with diabetes mellitus which have peripheral neuropathy; Other Names: ultasonographic evaluation
Control; Group II; healthy volunteers	Other: Ultrasonographic evaluation of nerves of healthy volunteers; evaluation of peripheral nerves and correlated with group I

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain scores on the visual analog scale	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Neuropathic pain scores on the Leeds Assessment of Neuropathic Symptoms and Signs pain scale	3 years

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Bayram Kelle, Cukurova University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: TF2012BAP13