UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035660 |
|---|---|
| Receipt number | R000040619 |
| Scientific Title | The impact of Dapagliflozin on epicardial fat volume |
| Date of disclosure of the study information | 2019/01/24 |
| Last modified on | 2019/01/24 21:14:55 |
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Basic information
Public title
The impact of Dapagliflozin on epicardial
fat volume
Acronym
Effects of Dapagliflozin on Body Composition
Scientific Title
The impact of Dapagliflozin on epicardial
fat volume
Scientific Title:Acronym
Effects of Dapagliflozin on Body Composition
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between an dapagliflozin and epicardial fat volume.
Basic objectives2
Others
Basic objectives -Others
To evaluate the impact of an dapagliflozin on inflammatory marker.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Epicardial fat volume
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dapagliflozin 5mg/day
Interventions/Control_2
optimal medical therapy except SGLT-2 inhibitor
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 DM
HbA1c>6.5%
no history of SGLT2 inhibitor-treatment
patients with on-going diet and exercise therapies
history of coronary artery disease
Key exclusion criteria
age > 75 years
insulin therapy
atrial fibrillation
renal insufficiency (estimated glomerular filtration rate < 45 mL/min/1.73 m2)
chronic inflammatory disease
coronary artery bypass graft surgery.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Sato |
Organization
Tachikawa general hospital
Division name
Cardiology
Zip code
Address
1-24 asahioka, Nagaoka city, Niigata prefecture Japan
TEL
0258-33-3111
kirotaro19731013@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Sato |
Organization
Tachikawa general hospital
Division name
Cardiology
Zip code
Address
1-24 asahioka, Nagaoka city, Niigata prefecture Japan
TEL
0258-33-3111
Homepage URL
kirotaro19731013@yahoo.co.jp
Sponsor or person
Institute
Tachikawa general hospital
Institute
Department
Personal name
Funding Source
Organization
Tachikawa general hospital
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 11 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 24 | Day |
Last modified on
| 2019 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040619
