Brief Summary
Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with Type 1 Diabetes.
Brief Title
Corneal Confocal Microscopy in Patients 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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Diabetic Neuropathies
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
35 Years
Minimum Age
18 Years
NCT Id
NCT03045250
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2016-6962
Overall Status
Withdrawn
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Corneal Confocal Microscopy in Patients With Type 1 Diabetes
Primary Outcomes
Outcome Description
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).
Outcome Measure
Corneal small nerve fiber damage
Outcome Time Frame
Assessed one time per subject during study (study completed over 3 years)
Outcome Description
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.
Outcome Measure
Normative values for corneal confocal microscopy (CCM)
Outcome Time Frame
Assessed one time per subject during study (study completed over 3 years)
Secondary Outcomes
Outcome Description
Measuring serum biomarkers (blood levels) leptin. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.
Outcome Time Frame
Assessed one time per subject during study (study completed over 3 years)
Outcome Measure
Serum biomarkers - leptin
Outcome Description
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.
Outcome Time Frame
Assessed one time per subject during study (study completed over 3 years)
Outcome Measure
Serum biomarkers - TNF Alpha
Outcome Description
Measuring serum biomarkers (blood levels) fibrinogen. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.
Outcome Time Frame
Assessed one time per subject during study (study completed over 3 years)
Outcome Measure
Serum biomarkers - fibrinogen
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
35
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Lisa Underland
Investigator Email
lunderla@montefiore.org
Investigator Phone
832-867-4580