Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
- Conditions
- NeuropathyType 1 DiabetesRetinopathy
- Interventions
- Procedure: Corneal Confocal MicroscopyProcedure: Nerve Conduction StudiesProcedure: Quantitative sensory testingProcedure: Neuropathy Symptom ScoreProcedure: Clinical nerve examination
- Registration Number
- NCT02321904
- Lead Sponsor
- University of Calgary
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Diabetic cases Quantitative sensory testing 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 Corneal Confocal Microscopy 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. Normal controls Nerve Conduction Studies 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. Normal controls Quantitative sensory testing 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. Diabetic cases Corneal Confocal Microscopy 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. Diabetic cases Nerve Conduction Studies 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. Diabetic cases Neuropathy Symptom Score 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 Neuropathy Symptom Score 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. Diabetic cases Clinical nerve examination 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 Clinical nerve examination 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.
- Primary Outcome Measures
Name Time Method The utility of corneal confocal microscopy to assess diabetic neuropathy in children. 2 years 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.
- Secondary Outcome Measures
Name Time Method Corneal nerve density (CND) by CCM Single time point To compare corneal nerve density (CND) between
1. children with T1D for 5 years or more to children without diabetes;
2. children with T1D with and without evidence of DN;
3. to examine the relationship between CND, CNL \& CBD and known risk factors of DNCorneal nerve length (CNL) by CCM. Single time point To compare corneal nerve length (CNL), by CCM between
1. children with T1D for 5 years or more to children without diabetes;
2. children with T1D with and without evidence of DN;
3. to examine the relationship between CND, CNL \& CBD and known risk factors of DNCorneal nerve branching density (CBD) by CCM Single time point To compare corneal nerve branching density (CBD) by CCM between
1. children with T1D for 5 years or more to children without diabetes;
2. children with T1D with and without evidence of DN;
3. to examine the relationship between CND, CNL \& CBD and known risk factors of DNChanges in corneal nerve morphology two years after the initial CCM exam. 2 years 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.
Trial Locations
- Locations (1)
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada