UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015060 |
|---|---|
| Receipt number | R000017523 |
| Scientific Title | Influence of glycemic variability on endothelial progenitor cells from peripheral blood of patients with type 1 diabetes |
| Date of disclosure of the study information | 2014/09/04 |
| Last modified on | 2017/11/02 10:58:26 |
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Basic information
Public title
Influence of glycemic variability on endothelial progenitor cells from peripheral blood of patients with type 1 diabetes
Acronym
Relation between glycemic variability and endothelial progenitor cells
Scientific Title
Influence of glycemic variability on endothelial progenitor cells from peripheral blood of patients with type 1 diabetes
Scientific Title:Acronym
Relation between glycemic variability and endothelial progenitor cells
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence of glycemic control and variability on number of peripheral blood endothelial progenitor cells in patients with type 1 diabetes.
Basic objectives2
Others
Basic objectives -Others
Comparison to patients with type 2 diabetes and healthy controls
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between parameters for glycemic variability which is measured by continuous glucose monitoring and number of peripheral blood endothelial progenitor cells
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
1.Measurement of blood glucose level
by CGM(Continuous Glucose Monitoring)
2.Taking blood samples
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 1 diabetes and type 2 diabetes and healthy controls
Key exclusion criteria
Pregnancy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihisa Imagawa |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka
TEL
072-683-1221
imagawa@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiharu Tsutsumi |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka
TEL
072-683-1221
Homepage URL
in1299@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
Address
Tel
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
大阪医科大学附属病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s13340-017-0335-x
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
| 2014 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 08 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 04 | Day |
Last modified on
| 2017 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017523
