UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of sodium-glucose co-transporter2(SGLT2) inhibitors on left ventricular systolic and/or diastolic dysfunction in Japanese type2 diabetes
Title of the study (Brief title)	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	Junko Hamai
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Department of Endocrinology and Diabetes
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	Junko Hamai
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Department of Endocrinology and Diabetes
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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