UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039614 |
|---|---|
| Receipt number | R000044120 |
| Scientific Title | Investigation for the association between complications of diabetes mellitus and corneal nerve fibers visualized by confocal microscopy |
| Date of disclosure of the study information | 2020/02/27 |
| Last modified on | 2024/03/05 15:14:37 |
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Basic information
Public title
Investigation for the association between complications of diabetes mellitus and corneal nerve fibers visualized by confocal microscopy
Acronym
Investigation for the association between complications of diabetes mellitus and corneal nerve fibers visualized by confocal microscopy
Scientific Title
Investigation for the association between complications of diabetes mellitus and corneal nerve fibers visualized by confocal microscopy
Scientific Title:Acronym
Investigation for the association between complications of diabetes mellitus and corneal nerve fibers visualized by confocal microscopy
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between complications of diabetes mellitus and morphological alteration of corneal nerve fivers visualized by confocal microscopy. We aim to establish the observation of corneal nerve fivers by confocal microscopy as a noninvasive evaluation factor of complications of diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
morphological alternation of corneal nerve fibers, severity of diabetic kidney disease, severity of diabetic neuropathy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The following tests are performed on all subjects in the same manner.
Tear test (Schirmer test, tear film breakage time)
Blood test items: fasting blood glucose, fasting C peptide, HbA1c, serum creatinine, eGFR
Urinalysis: qualitative reaction, quantitative (urine albumin or urine protein, urine creatinine)
Cornea perception
blood pressure
Achilles tendon reflex
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are at least 20 years old at the time of consent.
Patients who obtain written consent for participation in this study.
Key exclusion criteria
Patients with a history of ophthalmic surgery.
Patients with type 1 diabetes.
Patients who have or have a history of keratoconjunctival disease unrelated to diabetes.
Patients who have a history of or are currently suffering from a systemic disease other than diabetes that is expected to affect the cornea.
Patients who have a history of or are currently suffering from a neurological disorder other than diabetic neuropathy.
Patients who have or have a history of renal disease other than diabetic kidney disease.
Patients with a history of cervical and spine surgery.
Other patients who are deemed unsuitable for conducting the study by the principal or investigator
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Taiichiro |
| Middle name | |
| Last name | Chikama |
Organization
Hiroshima University Hospital
Division name
Department of Ophthalmology
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
082-257-5247
chikama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Shinji |
Organization
Hiroshima University Hospital
Division name
Department of Ophthalmology
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
082-257-5247
Homepage URL
shinjiko@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University Hospital, Department of Ophthalmology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Hospital, Department of Ophthalmology
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
Tel
082-257-5247
chikama@hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044120
