UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012756
Receipt number R000014566
Scientific Title Morphological and functional assessment of diabetic cardiomyopathy
Date of disclosure of the study information 2014/01/06
Last modified on 2014/01/05 11:30:00

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Basic information

Public title

Morphological and functional assessment of diabetic cardiomyopathy

Acronym

Evaluation of pathogenesis of diabetic cardiomyopathy

Scientific Title

Morphological and functional assessment of diabetic cardiomyopathy

Scientific Title:Acronym

Evaluation of pathogenesis of diabetic cardiomyopathy

Region

Japan


Condition

Condition

Diabetic cardiomyopaty and diabetes with normal cardiac function as controls

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of the study is to clarify whether myocardial microcirculatory disorder induces diabetic cardiomyopathy (DMCM). Ammonia-13 PET with adenosine stress testing study is used to measure the myocardial microcirculation, and Late Gd enhancement in cardiac MRI is also used as evidence of myocardial injury.

Basic objectives2

Others

Basic objectives -Others

To clarify whether myocardial microcirculatory disorder induces DMCM

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

We analyze difference in myocardial blood flow (MBF) at rest and stress, and myocardial flow reserve (MFR) as determined by ammonia-13 PET, cardiac function and size of LGE as determined by cardiac MRI between patients with DMCM and diabetes control.

Key secondary outcomes

We analyze relationship between coronary calcification and MBF and MFR. In diabetes controls, we compare the MBF and MFR with clinical characteristics such as HbA1c, fasting glucose, plasma cholesterol and diabetic history.


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

30 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

Diabetic patients who are followed up in diabetic center or Heart center in Tokyo Women's medical university. Inclusion criteria is normal cardiac function and no coronary stenosis in diabetic controls, and low LVEF< 45 % and no coronary stenosis in DMCM.

Key exclusion criteria

Severe renal dysfunction (CKD stage>=4)
Patients with other multiple complication who are unlikely to undergo proposed examinations.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuji Sakai

Organization

Tokyo Women's Medical University

Division name

Dept.of Diagnostic Imaging and Nuclear Medicine

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, zip 162-8666

TEL

03-3353-8111

Email

sakai.shuji@twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuru Momose

Organization

Tokyo Women's Medical University

Division name

Dept.of Diagnostic Imaging and Nuclear Medicine

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, zip 162-8666

TEL

03-3353-8111

Homepage URL


Email

momose.mitsuru@twmu.ac.jp


Sponsor or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research (KAKENHI)

Organization

Division

Category of Funding Organization

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

2014 Year 01 Month 06 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

Enrolling by invitation

Date of protocol fixation

2012 Year 03 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective study


Management information

Registered date

2014 Year 01 Month 05 Day

Last modified on

2014 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name