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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
