Diabetic NeuropathiesCCMNCT03045250
Corneal Confocal Microscopy in Patients With Type 1 Diabetes
A study testing Corneal confocal microscopy, Skin biopsy and Nerve conduction study in people with Diabetic Neuropathies, run by Albert Einstein College of Medicine.
Trial summary
Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with Type 1 Diabetes. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Corneal confocal microscopy, Skin biopsy and Nerve conduction study
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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%
Who cannot join
- For all subjects:
- Contact lens wearers
- Diseases that could damage the cornea, other than diabetes.
- Neurologic disease
- Psychiatric disease
- Amputation
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- 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
About this study
Assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with Type 1 Diabetes.
Read the 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.
- Conditions
- Diabetic Neuropathies
- Being tested
- Corneal confocal microscopy, Skin biopsy, Nerve conduction study, Blood draw
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal confocal microscopyDevice
Confocal miscroscopy will be used to assess corneal nerve changes due to hyperglycemia.
Skin biopsyProcedure or surgery
Skin biopsy will be used to assess the appearance of nerve fibers in subjects with type 1 diabetes.
Nerve conduction studyProcedure or surgery
Nerve conduction studies will be use to assess for neuropathy.
Blood drawOther
Subjects will undergo a one time blood draw for biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes | Active comparator | Subjects with known Type 1 diabetes Receives: Device: Corneal confocal microscopy; Procedure: Skin biopsy; Procedure: Nerve conduction study; Other: Blood draw |
| Healthy Controls | Placebo comparator | Healthy controls Receives: Device: Corneal confocal microscopy; Procedure: Nerve conduction study; Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Assessed one time per subject during study (study completed over 3 years)
Secondary outcomes (3)
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.
Measured: Assessed one time per subject during study (study completed over 3 years)
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.
Measured: Assessed one time per subject during study (study completed over 3 years)
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.
Measured: Assessed one time per subject during study (study completed over 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Aug 2018 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Underland, MD, Principal investigator, Montefiore Medical Center at Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045250
- Sponsor's protocol ID
- 2016-6962
- Acronym
- CCM
- Status last verified
- Aug 2018
- First submitted
- 13 Jan 2017
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Confocal Microscopy in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03045250
- Acronym / sponsor ID
- CCM / 2016-6962
- Conditions
- Diabetic Neuropathies
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes | Active comparator | Device: Corneal confocal microscopy, Procedure: Skin biopsy, Procedure: Nerve conduction study, Other: Blood drawSubjects with known Type 1 diabetes |
| Healthy Controls | Placebo comparator | Device: Corneal confocal microscopy, Procedure: Nerve conduction study, Other: Blood drawHealthy controls |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects with diabetes:
- 18-30 years (cohort 1), adolescents ages 13-17 years (cohort 2).
- Type 1 Diabetes diagnosed via standard ADA criteria
- Match for age and gender
- Hemoglobin A1c <6.5%
Key exclusion criteria (15 listed)
- Contact lens wearers
- Diseases that could damage the cornea, other than diabetes.
- Neurologic disease
- Psychiatric disease
- Amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal confocal microscopyConfocal miscroscopy will be used to assess corneal nerve changes due to hyperglycemia. | Device | Healthy Controls, Type 1 Diabetes |
| Skin biopsySkin biopsy will be used to assess the appearance of nerve fibers in subjects with type 1 diabetes. | Procedure or surgery | Type 1 Diabetes |
| Nerve conduction studyNerve conduction studies will be use to assess for neuropathy. | Procedure or surgery | Healthy Controls, Type 1 Diabetes |
| Blood drawSubjects will undergo a one time blood draw for biomarkers. | Other | Healthy Controls, Type 1 Diabetes |
Primary outcome
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).
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.
3 secondary outcomes
Serum biomarkers - leptin
Time frame: Assessed one time per subject during study (study completed over 3 years)
Serum biomarkers - TNF Alpha
Time frame: Assessed one time per subject during study (study completed over 3 years)
Serum biomarkers - fibrinogen
Time frame: Assessed one time per subject during study (study completed over 3 years)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Underland, MD principal investigator
Montefiore Medical Center at Albert Einstein College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Corneal confocal microscopy, Skin biopsy and Nerve conduction study in people with Diabetic Neuropathies, run by Albert Einstein College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal small nerve fiber damage (time frame: Assessed one time per subject during study (study completed over 3 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.