NCT03045250

Corneal Confocal Microscopy in Patients With Type 1 Diabetes

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Diabetic Neuropathies

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2018-08-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2017-02-07
• Last updated: 2018-09-04