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Corneal Confocal Microscopy in Patients With Type 1 Diabetes (CCM)

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ClinicalTrials.gov Identifier: NCT03045250
Recruitment Status : Withdrawn (Lack of funding)
First Posted : February 7, 2017
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Albert Einstein College of Medicine

Brief Summary:
Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with Type 1 Diabetes.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Device: Corneal confocal microscopy Procedure: Skin biopsy Procedure: Nerve conduction study Other: Blood draw Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Corneal Confocal Microscopy in Patients With Type 1 Diabetes
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Type 1 Diabetes
Subjects with known Type 1 diabetes
Device: Corneal confocal microscopy
Confocal miscroscopy will be used to assess corneal nerve changes due to hyperglycemia.

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

Procedure: Nerve conduction study
Nerve conduction studies will be use to assess for neuropathy.

Other: Blood draw
Subjects will undergo a one time blood draw for biomarkers.

Placebo Comparator: Healthy Controls
Healthy controls
Device: Corneal confocal microscopy
Confocal miscroscopy will be used to assess corneal nerve changes due to hyperglycemia.

Procedure: Nerve conduction study
Nerve conduction studies will be use to assess for neuropathy.

Other: Blood draw
Subjects will undergo a one time blood draw for biomarkers.




Primary Outcome Measures :
  1. Corneal small nerve fiber damage [ Time Frame: Assessed one time per subject during study (study completed over 3 years) ]
    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).

  2. Normative values for corneal confocal microscopy (CCM) [ Time Frame: Assessed one time per subject during study (study completed over 3 years) ]
    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 :
  1. Serum biomarkers - leptin [ Time Frame: Assessed one time per subject during study (study completed over 3 years) ]
    Measuring serum biomarkers (blood levels) leptin. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.

  2. Serum biomarkers - TNF Alpha [ Time Frame: Assessed one time per subject during study (study completed over 3 years) ]
    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.

  3. Serum biomarkers - fibrinogen [ Time Frame: Assessed one time per subject during study (study completed over 3 years) ]
    Measuring serum biomarkers (blood levels) fibrinogen. In participants with diabetes, comparing the blood level measurements of those with neuropathy vs. those without neuropathy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045250


Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Lisa Underland, MD Montefiore Medical Center at Albert Einstein College of Medicine

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Responsible Party: Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03045250    
Other Study ID Numbers: 2016-6962
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: September 4, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Neuropathies
Diabetes Mellitus
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications