NCT03045250

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2018

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

January 13, 2017

Last Update Submit

August 30, 2018

Conditions

Diabetic Neuropathies

Outcome Measures

Primary Outcomes (2)

  • 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).

    Assessed one time per subject during study (study completed over 3 years)

  • 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.

    Assessed one time per subject during study (study completed over 3 years)

Secondary Outcomes (3)

  • Serum biomarkers - leptin

    Assessed one time per subject during study (study completed over 3 years)

  • Serum biomarkers - TNF Alpha

    Assessed one time per subject during study (study completed over 3 years)

  • Serum biomarkers - fibrinogen

    Assessed one time per subject during study (study completed over 3 years)

Study Arms (2)

Type 1 Diabetes

ACTIVE COMPARATOR

Subjects with known Type 1 diabetes

Device: Corneal confocal microscopyProcedure: Skin biopsyProcedure: Nerve conduction studyOther: Blood draw

Healthy Controls

PLACEBO COMPARATOR

Healthy controls

Device: Corneal confocal microscopyProcedure: Nerve conduction studyOther: Blood draw

Interventions

Corneal confocal microscopyDEVICE

Confocal miscroscopy will be used to assess corneal nerve changes due to hyperglycemia.

Healthy ControlsType 1 Diabetes
Skin biopsyPROCEDURE

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

Type 1 Diabetes
Nerve conduction studyPROCEDURE

Nerve conduction studies will be use to assess for neuropathy.

Healthy ControlsType 1 Diabetes
Blood drawOTHER

Subjects will undergo a one time blood draw for biomarkers.

Healthy ControlsType 1 Diabetes

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with diabetes:
  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Lisa Underland, MD

    Montefiore Medical Center at Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

February 7, 2017

Study Start

August 1, 2018

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

September 4, 2018

Record last verified: 2018-08