UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035660
Receipt number R000040619
Scientific Title The impact of Dapagliflozin on epicardial fat volume
Date of disclosure of the study information 2019/01/24
Last modified on 2019/01/24 21:14:55

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Basic information

Public title

The impact of Dapagliflozin on epicardial
fat volume

Acronym

Effects of Dapagliflozin on Body Composition

Scientific Title

The impact of Dapagliflozin on epicardial
fat volume

Scientific Title:Acronym

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

1st name
Middle name
Last name Takao Sato

Organization

Tachikawa general hospital

Division name

Cardiology

Zip code


Address

1-24 asahioka, Nagaoka city, Niigata prefecture Japan

TEL

0258-33-3111

Email

kirotaro19731013@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takao Sato

Organization

Tachikawa general hospital

Division name

Cardiology

Zip code


Address

1-24 asahioka, Nagaoka city, Niigata prefecture Japan

TEL

0258-33-3111

Homepage URL


Email

kirotaro19731013@yahoo.co.jp


Sponsor or person

Institute

Tachikawa general hospital

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 24 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2016 Year 06 Month 15 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040619


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name