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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012756
Receipt No. 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

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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
Institute Tokyo Women's Medical University
Institute
Department

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
URL(English) https://upload.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


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