Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children

Type 1 Diabetes Clinical Trial

— CCM  

Official title:

Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321904
• Other study ID #: E-21944
• Status: Completed
• Start date: June 2008
• Est. completion date: August 2019

Study information

• Verified date: October 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: August 2019
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuropathy
• Peripheral Nervous System Diseases
• Retinopathy
• Type 1 Diabetes

Intervention

Procedure:
• Corneal Confocal Microscopy
Close-up pictures of the front part of the eye (the cornea)
• Nerve Conduction Studies
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
Standardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe.
• Neuropathy Symptom Score
A list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview.
• Clinical nerve examination
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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Corneal nerve density (CND) by CCM	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	Single time point
Secondary	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
Secondary	Corneal nerve length (CNL) by CCM.	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	Single time point
Secondary	Corneal nerve branching density (CBD) by CCM	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	Single time point