UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035355 |
|---|---|
| Receipt number | R000040285 |
| Scientific Title | Effects of canagliflozin on endothelial function and epicardial adipose tissue in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2018/12/24 |
| Last modified on | 2023/07/06 06:25:13 |
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Basic information
Public title
Effects of canagliflozin on endothelial function and epicardial adipose tissue in patients with type 2 diabetes mellitus
Acronym
Effects of canagliflozin on endothelial function and epicardial adipose tissue
Scientific Title
Effects of canagliflozin on endothelial function and epicardial adipose tissue in patients with type 2 diabetes mellitus
Scientific Title:Acronym
Effects of canagliflozin on endothelial function and epicardial adipose tissue
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of canagliflozin on endothelial function and epicardial adipose tissue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of endothelial function using peripheral near infrared spectroscopy and epicardial adipose tissue using cardiac computed tomography
Key secondary outcomes
Body weight, abdominal circumference, lipid metabolism, renal function, comparison between patients with and without statin therapy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Canagliflozin 100mg for 16 weeks
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 with type 2 diabetes mellitus who have not never been prescribed SGLT2 inhibitors.
Key exclusion criteria
Patients with atrial fibrillation.
Patient who is considered ineligible for enrolling this study by attending physician.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Keiichiro |
| Middle name | |
| Last name | Kuronuma |
Organization
Kawaguchi Municipal Medical Center
Division name
Department of Cardiology
Zip code
3330833
Address
180 Nishi-araijuku, Kawaguchi city, Japan
TEL
0482872525
keiichirokuronuma@gmail.com
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Kuronuma |
Organization
Kawaguchi Municipal Medical Center
Division name
Department of Cardiology
Zip code
333-0833
Address
180 Nishi-araijuku, Kawaguchi city, Japan
TEL
0482872525
Homepage URL
keiichirokuronuma@gmail.com
Sponsor or person
Institute
Kawaguchi Municipal Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawaguchi Municipal Medical Menter
Address
180 Nishi-araijuku, Kawaguchi city
Tel
0482872525
keiichirokuronuma@gmail.com
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
| 2018 | Year | 12 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 04 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040285
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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