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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025841
Receipt No. 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

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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
Email 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
Email femme-de-docilite@hotmail.co.jp

Sponsor
Institute Kanagawa Cardiovascular and Respiratory Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029713

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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