UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033765 |
|---|---|
| Receipt number | R000038516 |
| Scientific Title | Elucidation of the progression mechanism of retinopathy among carbohydrate metabolism disorders during pregnancy |
| Date of disclosure of the study information | 2018/08/15 |
| Last modified on | 2020/02/12 15:04:42 |
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Basic information
Public title
Elucidation of the progression mechanism of retinopathy among carbohydrate metabolism disorders during pregnancy
Acronym
Elucidation of the progression mechanism of retinopathy during pregnancy
Scientific Title
Elucidation of the progression mechanism of retinopathy among carbohydrate metabolism disorders during pregnancy
Scientific Title:Acronym
Elucidation of the progression mechanism of retinopathy during pregnancy
Region
| Japan |
Condition
Condition
carbohydrate metabolism disorders during pregnancy
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Ophthalmology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the mechanism of retinopathy progression in CMDP.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vascular concentration of various cytokine
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Female
Key inclusion criteria
1)Pregnant with pre-existing diabetes within 14w of pregnant
2)Pregnant without any complications
3)Normal pregnant women
4)Diabetic women without pregnancy
Key exclusion criteria
Those women with severe general complication or severe ocular complications.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Japan
TEL
059-231-5027
sugmochi@aqua.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, 514-8507, Japan
TEL
059-231-5027
Homepage URL
sugmochi@aqua.ocn.ne.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mie University Graduate School of Medicine
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
Mie University Graduate School of Medicine
Address
2-174 Edobashi, Tsu, Japan
Tel
059-231-5027
sugmochi@clin.medic.mie-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
三重大学医学部附属病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 15 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare and quantify vascular cytokine concentration
Management information
Registered date
| 2018 | Year | 08 | Month | 15 | Day |
Last modified on
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038516
