Corneal Confocal Microscopy in Patients With Type 1 Diabetes

NCT ID: NCT03045250

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-02-01

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Type 1 Diabetes

Subjects with known Type 1 diabetes

Group Type: ACTIVE_COMPARATOR

Corneal confocal microscopy

Intervention Type: DEVICE

Confocal miscroscopy will be used to assess corneal nerve changes due to hyperglycemia.

Skin biopsy

Intervention Type: PROCEDURE

Skin biopsy will be used to assess the appearance of nerve fibers in subjects with type 1 diabetes.

Nerve conduction study

Intervention Type: PROCEDURE

Nerve conduction studies will be use to assess for neuropathy.

Blood draw

Intervention Type: OTHER

Subjects will undergo a one time blood draw for biomarkers.

Healthy Controls

Healthy controls

Group Type: PLACEBO_COMPARATOR

Corneal confocal microscopy

Intervention Type: DEVICE

Confocal miscroscopy will be used to assess corneal nerve changes due to hyperglycemia.

Nerve conduction study

Intervention Type: PROCEDURE

Nerve conduction studies will be use to assess for neuropathy.

Blood draw

Intervention Type: OTHER

Subjects will undergo a one time blood draw for biomarkers.

Interventions

Corneal confocal microscopy

Confocal miscroscopy will be used to assess corneal nerve changes due to hyperglycemia.

Intervention Type: DEVICE

Skin biopsy

Skin biopsy will be used to assess the appearance of nerve fibers in subjects with type 1 diabetes.

Intervention Type: PROCEDURE

Nerve conduction study

Nerve conduction studies will be use to assess for neuropathy.

Intervention Type: PROCEDURE

Blood draw

Subjects will undergo a one time blood draw for biomarkers.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Underland, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center at Albert Einstein College of Medicine

Other Identifiers

2016-6962

Identifier Type: -

Identifier Source: org_study_id