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Trial record 2 of 80 for:    leptin and type 1 diabetes

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2017 by Albert Einstein College of Medicine, Inc.
Sponsor:
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT03045250
First received: January 13, 2017
Last updated: February 3, 2017
Last verified: February 2017
  Purpose
Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with Type 1 Diabetes.

Condition Intervention
Diabetic Neuropathies
Device: Corneal confocal microscopy
Procedure: Skin biopsy
Procedure: Nerve conduction study
Other: Blood draw

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Screening
Official Title: Corneal Confocal Microscopy in Patients With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine, Inc.:

Primary Outcome Measures:
  • 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). [ Time Frame: Assessed one time per subject, study to be completed over 3 years ]
    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). 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).

  • Estimate corneal nerve fiber damage in subjects with diabetes with peripheral neuropathy and subjects with diabetes without peripheral neuropathy, diagnosed by skin biopsy. [ Time Frame: Assessed one time per subject, study to be completed over 3 years ]
    Estimate corneal nerve fiber damage in subjects with diabetes with peripheral neuropathy and subjects with diabetes without peripheral neuropathy, diagnosed by skin biopsies (a small skin biopsy will be taken, and the number of nerve fibers in the outer layer will be counted) and nerve conduction studies which measure the time it takes for an impulse to move through a nerve. This is done by the use of small electrodes placed on the limb)

  • Obtain much needed normative values for CCM in adolescents and intraepidermal nerve fiber density from skin biopsies in subjects with type 1 diabetes. [ Time Frame: Assessed one time per subject, study to be 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:
  • As a secondary outcome measure, to compare serum biomarkers (blood levels) including leptin, TNF alpha, and fibrinogen in patients with diabetes comparing the blood level measurements of those with neuropathy vs. those without neuropathy. [ Time Frame: Assessed one time per subject, study to be completed over 3 years ]

Estimated Enrollment: 100
Anticipated Study Start Date: May 1, 2017
Estimated Study Completion Date: February 1, 2020
Estimated Primary Completion Date: February 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subjects with known 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.

  Show Detailed Description

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03045250

Contacts
Contact: Lisa J Underland, DO 718 920 4664 ext 4155 lunderla@montefiore.org
Contact: Ranjitha Katikaneni, MBBS 718 920 4664 rkatikan@montefiore.org

Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Rubina Heptulla, Physician, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT03045250     History of Changes
Other Study ID Numbers: 2016-6962 
Study First Received: January 13, 2017
Last Updated: February 3, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 24, 2017