UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026335 |
|---|---|
| Receipt number | R000030237 |
| Scientific Title | Investigation abut the relationship between systemic sympathetic nerve activity and use of SGLT2 inhibitor in patients with type2 diabetes mellitus. |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2021/03/04 01:40:28 |
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Basic information
Public title
Investigation abut the relationship between systemic sympathetic nerve activity and use of SGLT2 inhibitor in patients with type2 diabetes mellitus.
Acronym
Investigation abut the relationship between systemic sympathetic nerve activity and use of SGLT2 inhibitor in patients with type2 diabetes mellitus.
Scientific Title
Investigation abut the relationship between systemic sympathetic nerve activity and use of SGLT2 inhibitor in patients with type2 diabetes mellitus.
Scientific Title:Acronym
Investigation abut the relationship between systemic sympathetic nerve activity and use of SGLT2 inhibitor in patients with type2 diabetes mellitus.
Region
| Japan |
Condition
Condition
Type2 diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether SGLT2 inhibitor could reduce sympathetic nerve activity in patients with type2 diabetes mellitus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The comparison of muscle sympathetic nerve activity between baseline and 24 week after implementation of dapagliflozin therapy.
Key secondary outcomes
To compare the difference of primary outcome between patients complicated with heart failure and patients without heart failure.
To compare the difference of echocardiographic parameters(EF,E/E',etc.) and labor data(BNP,etc.) between baseline and 24 week after implementation of dapagliflozin 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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Taking dapagliflozin 5mg/day.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type2 diabetes mellitus patients
HbA1c 7-10%
Key exclusion criteria
Patients who can't indicate one's intention
History of myocardial infarction within 3 months before.
Complicated with lung disease
renal failure( eGFR<45)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuto Hamaoka |
Organization
Kanazawa university
Division name
Graduate school of advanced preventive medical science, system biology
Zip code
Address
13-1, Takara-machi, Kanazawa city, Ishikawa prefecture
TEL
076-265-2233
tokuta114@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuto Hamaoka |
Organization
Kanazawa university
Division name
Graduate school of advanced preventive medical science, system biology
Zip code
Address
13-1, Takara-machi, Kanazawa city, Ishikawa prefecture
TEL
076-265-2233
Homepage URL
tokuta114@yahoo.co.jp
Sponsor or person
Institute
Kanazawa university, graduate school of advanced preventive medical science, system biology
Institute
Department
Personal name
Funding Source
Organization
Kanazawa university, graduate school of advanced preventive medical science, system biology
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
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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | 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
| 2017 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 28 | Day |
Last modified on
| 2021 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030237
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/03/01 | 研究計画書SGLT2216.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
