UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025841 |
|---|---|
| Receipt number | R000029713 |
| Scientific Title | Effects of sodium-glucose co-transporter2(SGLT2) inhibitors on left ventricular systolic and/or diastolic dysfunction in Japanese type2 diabetes |
| Date of disclosure of the study information | 2017/01/25 |
| Last modified on | 2017/01/25 15:40:53 |
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Basic information
Public title
Effects of sodium-glucose co-transporter2(SGLT2) inhibitors on left ventricular systolic and/or diastolic dysfunction in Japanese type2 diabetes
Acronym
Effects of sodium-glucose co-transporter2(SGLT2)inhibitors on left ventricular dysfunction
Scientific Title
Effects of sodium-glucose co-transporter2(SGLT2) inhibitors on left ventricular systolic and/or diastolic dysfunction in Japanese type2 diabetes
Scientific Title:Acronym
Effects of sodium-glucose co-transporter2(SGLT2)inhibitors on left ventricular dysfunction
Region
| Japan |
Condition
Condition
Type2 diabetic patients with systolic and/or diastolic dysfunction
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effect of SGLT2 inhibitor(dapagliflozin) on left ventricular systolic and/or diastolic function by means of echography and BNP in type2 diabetic patients with left ventricular systolic and/or diastolic dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Left ventricular diastolic function by echocardiography after 52 week with dapaglifrogin (LVMI,E/e',e')
Key secondary outcomes
BNP or pro BNP after 24 week and 52 week with dapaglifrogin
Left ventricular systolic function by echocardiography after 52 week with dapaglifrogin
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1Type2DM patients those who have been treated with the dietary therapy, therapeutic excercise, and diabetec medicene, and whose blood glucose has not been sufficient controlled.
2The patients with left ventricular diastolic or/and systolic dysfunction
320=<age<75 years old
Key exclusion criteria
1patients with type1 diabetes
2Patients with severe infection, perioperative, severe ketosis, severeinjury
3Patients with mild renal dysfunction(sCr>1.5mg/dl)
4Patients with severe heart failure(NYHA class 4)
5Patients with serious hepatic dysfunction
6Patients with mild MR
7Patients with atrial fibrillation
8Patients with risk of dehydration
9Patients with malignancy
10Patients with malnutrition, stavation
11Patients who are pregnant, breastfeeding or may become pregnant
12Patients taking SGLT2I
13Patients who considered not eligible for the study by the attending doctor due to other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Hamai |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
6-16-1 Tomioka-higashi ,Kanazawa-ku,Yokohama,Kanagawa,236-0051,Japan
TEL
045-701-9581
femme-de-docilite@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Hamai |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
6-16-1 Tomioka-higashi ,Kanazawa-ku,Yokohama,Kanagawa,236-0051,Japan
TEL
045-701-9581
Homepage URL
femme-de-docilite@hotmail.co.jp
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Other
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
神奈川県立循環器呼吸器病センター
Kanagawa Cardiovascular and Respiratory Center
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 25 | 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 | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | 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
Prospective ovservational study
Recruitment period: from January 2017 to March 2020
Management information
Registered date
| 2017 | Year | 01 | Month | 25 | Day |
Last modified on
| 2017 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029713
