Corneal Confocal Microscopy in Patients With Type 1 Diabetes

Diabetic Neuropathies Clinical Trial

— CCM  

Official title:

Corneal Confocal Microscopy in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03045250
• Other study ID #: 2016-6962
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: August 2018
• Source: Albert Einstein College of Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with Type 1 Diabetes.

Description:

Rationale: Poorly controlled diabetes mellitus is associated with microvascular complications, which includes peripheral neuropathy. Peripheral neuropathy associated with diabetes is a painful condition. Its diagnosis is hampered by painful and long nerve conduction studies which fail to diagnose small nerve neuropathy. It is important to study methods of noninvasive methods of early detection, which are sensitive and specific in diagnosing early neuropathy and we propose a novel study that this can be detected in the cornea of the eye.

Aims:

• Estimate corneal small nerve fiber damage in young T1DM subjects (corneal fiber density, nerve branch density, and fiber length) and compare the results to healthy controls using corneal confocal microscopy (CCM).

• Estimate corneal nerve fiber damage in subjects with diabetes, with peripheral neuropathy and subjects with diabetes without peripheral neuropathy, diagnosed by skin biopsies and nerve conduction studies

• Obtain much needed normative values for CCM in adolescents and intraepidermal nerve fiber density from skin biopsies in subjects with type 1 diabetes.

• As a secondary outcome measure, to compare serum biomarkers including leptin, TNF alpha, and fibrinogen in patients with diabetes in those with neuropathy Vs. without neuropathy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion:

• Subjects with diabetes:

• 18-30 years (cohort 1), adolescents ages 13-17 years (cohort 2).

• Type 1 Diabetes diagnosed via standard ADA criteria

Matched Controls:

• Match for age and gender

• Hemoglobin A1c <6.5%

Exclusion:

For all subjects:

• Contact lens wearers

• Diseases that could damage the cornea, other than diabetes.

• Neurologic disease

• Psychiatric disease

• Amputation

• Foot ulcers

• Pain not of neuropathic origin.

• Presence of Lupus, Sjogren's syndrome and Celiac disease

• Hyperlipidemia requiring lipid-lowering medications

• Peripheral vascular disease

• Neuropathy due to anything besides diabetes

• Presence of any medical condition that may affect nerve conduction (e.g., radiculopathy).

For healthy controls

• Family history of Type 1 Diabetes

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetic Neuropathies

Intervention

Device:
• Corneal confocal microscopy
Confocal miscroscopy will be used to assess corneal nerve changes due to hyperglycemia.

Procedure:
• Skin biopsy
Skin biopsy will be used to assess the appearance of nerve fibers in subjects with type 1 diabetes.
• Nerve conduction study
Nerve conduction studies will be use to assess for neuropathy.

Other:
• Blood draw
Subjects will undergo a one time blood draw for biomarkers.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal small nerve fiber damage	Estimate corneal small nerve fiber damage in young T1DM subjects and compare the results to healthy controls using corneal confocal microscopy (CCM). This will be done by examining the cornea via confocal microscopy and obtaining images. These images will be evaluated looking at how many nerves there are, how they branch, and how long they are).	Assessed one time per subject during study (study completed over 3 years)
Primary	Normative values for corneal confocal microscopy (CCM)	Obtain much needed normative values for CCM in adolescents and intraepidermal nerve fiber density from skin biopsies in subjects with type 1 diabetes. This will be done by obtaining a small biopsy of skin and looking at the number of nerve fibers in the outer layer of the skin.	Assessed one time per subject during study (study completed over 3 years)
Secondary	Serum biomarkers - leptin	Measuring serum biomarkers (blood levels) leptin. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.	Assessed one time per subject during study (study completed over 3 years)
Secondary	Serum biomarkers - TNF Alpha	Measuring serum biomarkers (blood levels) Tumor Necrosis Factor (TNF) Alpha. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.	Assessed one time per subject during study (study completed over 3 years)
Secondary	Serum biomarkers - fibrinogen	Measuring serum biomarkers (blood levels) fibrinogen. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.	Assessed one time per subject during study (study completed over 3 years)