Corneal Confocal Microscopy in Patients With Type 1 Diabetes (CCM)
Primary Purpose
Diabetic Neuropathies
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Corneal confocal microscopy
Skin biopsy
Nerve conduction study
Blood draw
Sponsored by
About this trial
This is an interventional screening trial for 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Type 1 Diabetes
Healthy Controls
Arm Description
Subjects with known Type 1 diabetes
Healthy controls
Outcomes
Primary Outcome Measures
Corneal small nerve fiber damage
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).
Normative values for corneal confocal microscopy (CCM)
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.
Secondary Outcome Measures
Serum biomarkers - leptin
Measuring serum biomarkers (blood levels) leptin. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.
Serum biomarkers - TNF Alpha
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.
Serum biomarkers - fibrinogen
Measuring serum biomarkers (blood levels) fibrinogen. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.
Full Information
NCT ID
NCT03045250
First Posted
January 13, 2017
Last Updated
August 30, 2018
Sponsor
Albert Einstein College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03045250
Brief Title
Corneal Confocal Microscopy in Patients With Type 1 Diabetes
Acronym
CCM
Official Title
Corneal Confocal Microscopy in Patients With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type 1 Diabetes
Arm Type
Active Comparator
Arm Description
Subjects with known Type 1 diabetes
Arm Title
Healthy Controls
Arm Type
Placebo Comparator
Arm Description
Healthy controls
Intervention Type
Device
Intervention Name(s)
Corneal confocal microscopy
Intervention Description
Confocal miscroscopy will be used to assess corneal nerve changes due to hyperglycemia.
Intervention Type
Procedure
Intervention Name(s)
Skin biopsy
Intervention Description
Skin biopsy will be used to assess the appearance of nerve fibers in subjects with type 1 diabetes.
Intervention Type
Procedure
Intervention Name(s)
Nerve conduction study
Intervention Description
Nerve conduction studies will be use to assess for neuropathy.
Intervention Type
Other
Intervention Name(s)
Blood draw
Intervention Description
Subjects will undergo a one time blood draw for biomarkers.
Primary Outcome Measure Information:
Title
Corneal small nerve fiber damage
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).
Time Frame
Assessed one time per subject during study (study completed over 3 years)
Title
Normative values for corneal confocal microscopy (CCM)
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.
Time Frame
Assessed one time per subject during study (study completed over 3 years)
Secondary Outcome Measure Information:
Title
Serum biomarkers - leptin
Description
Measuring serum biomarkers (blood levels) leptin. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.
Time Frame
Assessed one time per subject during study (study completed over 3 years)
Title
Serum biomarkers - TNF Alpha
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.
Time Frame
Assessed one time per subject during study (study completed over 3 years)
Title
Serum biomarkers - fibrinogen
Description
Measuring serum biomarkers (blood levels) fibrinogen. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.
Time Frame
Assessed one time per subject during study (study completed over 3 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Underland, MD
Organizational Affiliation
Montefiore Medical Center at Albert Einstein College of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Corneal Confocal Microscopy in Patients With Type 1 Diabetes
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