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NCT Number: NCT02321904

Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Corneal Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Neuropathy Nutritional and Metabolic Diseases Retinal Diseases Retinopathy

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alberta Children's Hospital

Calgary, Alberta, T2M 1V5, Canada

About this study

In phase 1: To compare corneal nerve density (CND), length (CNL), and branching (CBD) by CCM between

  • children with type 1 diabetes for 5 years or more to children without diabetes;
  • children with type 1 diabetes with and without evidence of diabetic neuropathy;
  • to examine the relationship between CND, CNL & CBD and known risk factors of diabetic neuropathy

In phase 2:

  • to examine for changes in corneal nerve morphology two years after the initial CCM exam.
  • to describe the evolution of diabetic neuropathy based on clinical symptoms, neurological deficits, and other tests of nerve dysfunction.
  • to assess if changes in corneal nerve morphology correlate with changes in nerve conduction velocity and autonomic testing.
  • To examine the risk factors associated with progression of diabetic neuropathy in our pediatric population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corneal Confocal Microscopy

Procedure

Close-up pictures of the front part of the eye (the cornea)

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.

Quantitative sensory testing

Procedure

Standardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe.

Neuropathy Symptom Score

Procedure

A list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview.

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.

Primary outcomes

  1. The utility of corneal confocal microscopy to assess diabetic neuropathy in children.

    Time frame: 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 outcomes

  1. Corneal nerve density (CND) by CCM

    Time frame: Single time point

    To compare corneal nerve density (CND) between

    • children with T1D for 5 years or more to children without diabetes;
    • children with T1D with and without evidence of DN;
    • to examine the relationship between CND, CNL & CBD and known risk factors of DN

  2. Changes in corneal nerve morphology two years after the initial CCM exam.

    Time frame: 2 years

    In phase 2 : 1) to examine for changes in corneal nerve morphology two years after the initial CCM exam.

    • to describe the evolution of DN in based on clinical symptoms, neurological deficits, and other tests of nerve dysfunction.
    • 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.

  3. Corneal nerve length (CNL) by CCM.

    Time frame: Single time point

    To compare corneal nerve length (CNL), by CCM between

    • children with T1D for 5 years or more to children without diabetes;
    • children with T1D with and without evidence of DN;
    • to examine the relationship between CND, CNL & CBD and known risk factors of DN

  4. Corneal nerve branching density (CBD) by CCM

    Time frame: Single time point

    To compare corneal nerve branching density (CBD) by CCM between

    • children with T1D for 5 years or more to children without diabetes;
    • children with T1D with and without evidence of DN;
    • to examine the relationship between CND, CNL & CBD and known risk factors of DN

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Acronym: CCM

Important dates

Study start
2008
Primary completion
2014
Study completion
2019
First posted
Dec 22, 2014
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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