UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of Dapagliflozin on epicardial fat volume
Title of the study (Brief title)	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	Takao Sato
Organization	Tachikawa general hospital
Division name	Cardiology
Address	1-24 asahioka, Nagaoka city, Niigata prefecture Japan
TEL	0258-33-3111
Email	kirotaro19731013@yahoo.co.jp

Public contact
Name of contact person	Takao Sato
Organization	Tachikawa general hospital
Division name	Cardiology
Address	1-24 asahioka, Nagaoka city, Niigata prefecture Japan
TEL	0258-33-3111
Homepage URL
Email	kirotaro19731013@yahoo.co.jp

Sponsor
Institute	Tachikawa general hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040619