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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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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.
In phase 1: To compare corneal nerve density (CND), length (CNL), and branching (CBD) by CCM between
In phase 2:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal Confocal Microscopy | Procedure | Close-up pictures of the front part of the eye (the cornea) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal nerve density (CND) by CCM | To compare corneal nerve density (CND) between
| Single time point |
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Inclusion Criteria:
Exclusion Criteria:
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Cases: Children seen at the Alberta Children's Hospital Diabetes Clinic in Calgary Controls: 8-18 year old healthy children
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| Name | Affiliation | Role |
|---|---|---|
| Danièle Pacaud, Md, FRCPC | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital | Calgary | Alberta | T2M 1V5 | Canada |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D012164 | Retinal Diseases |
| D003316 | Corneal Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Nerve Conduction Studies | Procedure | 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. |
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| Quantitative sensory testing | Procedure | Standardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe. |
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| Neuropathy Symptom Score | Procedure | A list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview. |
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| Clinical nerve examination | Procedure | 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. |
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| Changes in corneal nerve morphology two years after the initial CCM exam. |
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 DN in 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 DN in our pediatric population. |
| 2 years |
| Corneal nerve length (CNL) by CCM. | To compare corneal nerve length (CNL), by CCM between
| Single time point |
| Corneal nerve branching density (CBD) by CCM | To compare corneal nerve branching density (CBD) by CCM between
| Single time point |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005128 | Eye Diseases |