Clinical trial NCT02321904: Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
Official title: Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Neuropathy
Retinopathy
Keywords: Confocal microscopy
Cornea
Neuropathy
Detection
Diabetes
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2014-12-22
Enrollment: 176
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases: Children seen at the Alberta Children's Hospital Diabetes Clinic in Calgary Controls: 8-18 year old healthy children

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.

Eligibility criteria: 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

Primary outcomes:
measure: The utility of corneal confocal microscopy to assess diabetic neuropathy in children.
timeFrame: 2 years
Secondary outcomes:
measure: Corneal nerve density (CND) by CCM
timeFrame: Single time point
measure: Changes in corneal nerve morphology two years after the initial CCM exam.
timeFrame: 2 years
measure: Corneal nerve length (CNL) by CCM.
timeFrame: Single time point
measure: Corneal nerve branching density (CBD) by CCM
timeFrame: Single time point
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Danièle Pacaud, Md, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: