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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Withdrawn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
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetic Neuropathies

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 13, 2017
    Last Updated
    August 30, 2018
    Sponsor
    Albert Einstein College of Medicine
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    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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