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Ultrasonographic Evaluation of Diabetic Neuropathy

NCT ID: NCT02308059

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Diabetic Peripheral Neuropathy

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with diabetes mellitus

Group I; the patients with diabetes mellitus who had peripheral neuropathy as diagnosed.

Ultrasonographic evaluation of nerves in diabetic patients

Intervention Type OTHER

Ultrasonographic evaluation of peripheral nerves in patients with diabetes mellitus which have peripheral neuropathy

Control

Group II; healthy volunteers

Ultrasonographic evaluation of nerves of healthy volunteers

Intervention Type OTHER

evaluation of peripheral nerves and correlated with group I

Interventions

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Ultrasonographic evaluation of nerves in diabetic patients

Ultrasonographic evaluation of peripheral nerves in patients with diabetes mellitus which have peripheral neuropathy

Intervention Type OTHER

Ultrasonographic evaluation of nerves of healthy volunteers

evaluation of peripheral nerves and correlated with group I

Intervention Type OTHER

Other Intervention Names

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ultasonographic evaluation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Bayram Kelle

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bayram Kelle

Role: PRINCIPAL_INVESTIGATOR

Çukurova University, Faculty of Medicine

Other Identifiers

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TF2012BAP13

Identifier Type: -

Identifier Source: org_study_id