Overview

This trial is active, not recruiting.

Conditions type 1 diabetes, neuropathy, retinopathy
Treatments corneal confocal microscopy, nerve conduction studies, quantitative sensory testing, neuropathy symptom score, clinical nerve examination
Sponsor University of Calgary
Collaborator Juvenile Diabetes Research Foundation
Start date June 2008
End date August 2014
Trial size 176 participants
Trial identifier NCT02321904, E-21944

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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.
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.

Primary Outcomes

Measure
The utility of corneal confocal microscopy to assess diabetic neuropathy in children.
time frame: 2 years

Secondary Outcomes

Measure
Corneal nerve density (CND) by CCM
time frame: Single time point
Changes in corneal nerve morphology two years after the initial CCM exam.
time frame: 2 years
Corneal nerve length (CNL) by CCM.
time frame: Single time point
Corneal nerve branching density (CBD) by CCM
time frame: Single time point

Eligibility Criteria

Male or female participants from 8 years up to 18 years old.

Inclusion Criteria: - CASES: Children with Type 1 Diabetes 8 to 18 years old followed at the Alberta Children's Hospital Diabetes Clinic with a duration of diabetes of at least 5 years. - CONTROLS: Healthy children aged 8 to 18 years. Exclusion Criteria: - Patients with known history of corneal abnormality, trauma, or surgery - 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

Additional Information

Official title Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
Principal investigator Danièle Pacaud, Md, FRCPC
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Calgary.