Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children

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.

Conditions

• Type 1 Diabetes
• Neuropathy
• Retinopathy

Interventions

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.

Sponsors & Collaborators

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Danièle Pacaud, Md, FRCPC · University of Calgary

Eligibility

Min Age

8 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2014-08-31

Completion

2019-08-31

Countries

• Canada

Study Locations