Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
CCM
1 other identifier
observational
176
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 22, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedOctober 3, 2019
October 1, 2019
6.2 years
June 17, 2013
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The utility of corneal confocal microscopy to assess diabetic neuropathy in children.
To confirm the utility of corneal confocal microscopy (CCM) as a new technique to rapidly assess diabetic neuropathy (DN) in children. This non-invasive eye imaging method may be a superior alternative to traditional nerve conduction studies. This study will be divided into two phases: Phase 1 will be a cross-sectional study of children with Type 1 Diabetes (T1D) and normal controls, while phase 2 will be a longitudinal assessment of a subgroup of T1D children recruited during Phase 1.
2 years
Secondary Outcomes (4)
Corneal nerve density (CND) by CCM
Single time point
Changes in corneal nerve morphology two years after the initial CCM exam.
2 years
Corneal nerve length (CNL) by CCM.
Single time point
Corneal nerve branching density (CBD) by CCM
Single time point
Study Arms (2)
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.
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.
Interventions
Close-up pictures of the front part of the eye (the cornea)
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.
Standardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe.
A list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview.
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
Cases: Children seen at the Alberta Children's Hospital Diabetes Clinic in Calgary Controls: 8-18 year old healthy children
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Juvenile Diabetes Research Foundationcollaborator
Study Sites (1)
Alberta Children's Hospital
Calgary, Alberta, T2M 1V5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danièle Pacaud, Md, FRCPC
University of Calgary
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 17, 2013
First Posted
December 22, 2014
Study Start
June 1, 2008
Primary Completion
August 1, 2014
Study Completion
August 1, 2019
Last Updated
October 3, 2019
Record last verified: 2019-10