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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035355
Receipt No. 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 2018/12/26

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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
Middle name
Last name Keiichiro Kuronuma
Organization Kawaguchi Municipal Medical Center
Division name Department of Cardiology
Zip code
Address 180 Nishi-araijuku, Kawaguchi city, Japan
TEL 0482872525
Email keiichirokuronuma@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Keiichiro Kuronuma
Organization Kawaguchi Municipal Medical Center
Division name Department of Cardiology
Zip code
Address 180 Nishi-araijuku, Kawaguchi city, Japan
TEL 0482872525
Homepage URL
Email keiichirokuronuma@gmail.com

Sponsor
Institute Kawaguchi Municipal Medical Center
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2018 Year 12 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 24 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040285

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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