Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
NCT ID: NCT02321904
Last Updated: 2019-10-03
Study Results
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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COMPLETED
176 participants
OBSERVATIONAL
2008-06-30
2019-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Diabetic cases
Children with Type 1 Diabetes 8 to 18 years old followed at the Alberta Children's Hospital Diabetes Clinic with duration of diabetes for at least 5 years will undergo Corneal Confocal Microscopy, Nerve Conduction Studies, Quantitative sensory testing, Neuropathy Symptom Scoring and Clinical nerve examinations.
Corneal Confocal Microscopy
Close-up pictures of the front part of the eye (the cornea)
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.
Quantitative sensory testing
Standardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe.
Neuropathy Symptom Score
A list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview.
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.
Normal controls
Healthy children aged 8 to 18 years will undergo Corneal Confocal Microscopy, Nerve Conduction Studies, Quantitative sensory testing, Neuropathy Symptom Scoring and Clinical nerve examinations.
Corneal Confocal Microscopy
Close-up pictures of the front part of the eye (the cornea)
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.
Quantitative sensory testing
Standardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe.
Neuropathy Symptom Score
A list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview.
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.
Interventions
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Corneal Confocal Microscopy
Close-up pictures of the front part of the eye (the cornea)
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.
Quantitative sensory testing
Standardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe.
Neuropathy Symptom Score
A list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview.
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.
Eligibility Criteria
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Inclusion Criteria
* CONTROLS: Healthy children aged 8 to 18 years.
Exclusion Criteria
* Any other cause of neuropathy
* Individuals with uncontrolled hypothyroidism
* Individuals with celiac disease
* Other serious chronic illnesses besides diabetes
* Inability to cooperate with testing
* Families unwilling to provide written informed consent
8 Years
18 Years
ALL
Yes
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
University of Calgary
OTHER
Responsible Party
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Dr. Danièle Pacaud
Associate Professor
Principal Investigators
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Danièle Pacaud, Md, FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Alberta Children's Hospital
Calgary, Alberta, Canada
Countries
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Other Identifiers
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E-21944
Identifier Type: -
Identifier Source: org_study_id
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