Clinical trial NCT03045250: Corneal Confocal Microscopy in Patients With Type 1 Diabetes
Official title: Corneal Confocal Microscopy in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Neuropathies
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Corneal small nerve fiber damage
timeFrame: Assessed one time per subject during study (study completed over 3 years)
measure: Normative values for corneal confocal microscopy (CCM)
timeFrame: Assessed one time per subject during study (study completed over 3 years)
Secondary outcomes:
measure: Serum biomarkers - leptin
timeFrame: Assessed one time per subject during study (study completed over 3 years)
measure: Serum biomarkers - TNF Alpha
timeFrame: Assessed one time per subject during study (study completed over 3 years)
measure: Serum biomarkers - fibrinogen
timeFrame: Assessed one time per subject during study (study completed over 3 years)
Other outcomes:
Locations:
Study officials:
affiliation: Montefiore Medical Center at Albert Einstein College of Medicine
name: Lisa Underland, MD
role: PRINCIPAL_INVESTIGATOR
References: