NCT02321904

Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 176 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Accepted

Summary

The overall aim of this study is to confirm the utility of corneal confocal microscopy (CCM) as a new technique to rapidly and non-invasively assess diabetic neuropathy (DN) in children. This study will be divided into two phases: Phase 1 will be a cross-sectional study of children with type 1 diabetes and normal controls, while phase 2 will be a longitudinal assessment of a subgroup of children with type 1 diabetes recruited during Phase 1.

Detailed description

In phase 1: To compare corneal nerve density (CND), length (CNL), and branching (CBD) by CCM between 1. children with type 1 diabetes for 5 years or more to children without diabetes; 2. children with type 1 diabetes with and without evidence of diabetic neuropathy; 3. to examine the relationship between CND, CNL \& CBD and known risk factors of diabetic neuropathy In phase 2: 1. to examine for changes in corneal nerve morphology two years after the initial CCM exam. 2. to describe the evolution of diabetic neuropathy based on clinical symptoms, neurological deficits, and other tests of nerve dysfunction. 3. to assess if changes in corneal nerve morphology correlate with changes in nerve conduction velocity and autonomic testing. 4. To examine the risk factors associated with progression of diabetic neuropathy in our pediatric population.

Conditions

• Type 1 Diabetes
• Neuropathy
• Retinopathy

Interventions

Type	Name	Description
PROCEDURE	Corneal Confocal Microscopy	Close-up pictures of the front part of the eye (the cornea)
PROCEDURE	Nerve Conduction Studies	The following assessments will be made: a) amplitude of nerve action potential (μV) and conduction velocity (m/s) of the sural sensory nerve by antidromic stimulation; b) motor nerve conduction velocity (m/s), maximum M-wave amplitude (mV) and motor nerve distal latency (ms) of the peroneal motor nerve; and c) tibial nerve conduction study will also be obtained if tolerated.
PROCEDURE	Quantitative sensory testing	Standardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe.
PROCEDURE	Neuropathy Symptom Score	A list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview.
PROCEDURE	Clinical nerve examination	Summated score of the lower extremities. Neurological examination assessing muscle strength, knee and ankle reflexes, sensation in the great toes will be evaluated for light touch-pressure, temperature, pin-prick, vibratory sense and joint position sense.

Timeline

• Start date: 2008-06-01
• Primary completion: 2014-08-01
• Completion: 2019-08-01
• First posted: 2014-12-22
• Last updated: 2019-10-03

Locations

1 site across 1 country: Canada