Corneal Confocal Microscopy in Patients With Type 1 Diabetes (CCM)

Albert Einstein College of Medicine

Status: Withdrawn

Conditions: Diabetic Neuropathies

Treatments: Device: Corneal confocal microscopy; Procedure: Nerve conduction study; Procedure: Skin biopsy; Other: Blood draw

Study type: Interventional

Funder types: Other

Identifiers

NCT03045250

2016-6962

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Type 1 Diabetes

Active Comparator group

Description:

Subjects with known Type 1 diabetes

Treatment:

Other: Blood draw

Procedure: Skin biopsy

Device: Corneal confocal microscopy

Procedure: Nerve conduction study

Healthy Controls

Placebo Comparator group

Description:

Healthy controls

Treatment:

Other: Blood draw

Device: Corneal confocal microscopy

Procedure: Nerve conduction study