UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014765 |
|---|---|
| Receipt number | R000017172 |
| Scientific Title | Investigation of the progression of atherosclerosis and atherosclerotic risk factor in patients with diabetes |
| Date of disclosure of the study information | 2014/08/06 |
| Last modified on | 2020/08/04 09:51:46 |
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Basic information
Public title
Investigation of the progression of atherosclerosis and atherosclerotic risk factor in patients with diabetes
Acronym
Diabetes and progression of atherosclerosis and risk factor
Scientific Title
Investigation of the progression of atherosclerosis and atherosclerotic risk factor in patients with diabetes
Scientific Title:Acronym
Diabetes and progression of atherosclerosis and risk factor
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the progression of atherosclerosis and atherosclerotic risk factor in patients with diabetes
Basic objectives2
Others
Basic objectives -Others
Cohort
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) All cause death,
2)Cardiovascular events (composite of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemic stroke, hospitalization for heart failure, coronary revascularization, or hospitalization for peripheral artery disease)
3)new onset cardiovascular disease
4)new onset LV dysfunction
5)plaque volume (coronary and carotid)
6)BMI
Key secondary outcomes
1)Change in endothelial function
2)New onset of cardic valvular disease
3)New onset of arrythmia
4) Change in fasting glucose, HbA1c, body weight, insulin resistance and secretion, BNP, Hs-CRP, lipids, PUFAs, UACA, CTR, ABI, cartid echography, and ECG.
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diabetes over 45 age.
Key exclusion criteria
1.post PCI and CABG
2.post implantation of peacemaker and ICD or CRT
3.cardiac shock
4.severe heart failure (more than NYHA3)
5.Cre more than1.5mg/dl
6.pheochromocytoma
7.bronchial asthma
8.Allergy of contrast agent
9.Severe thyroid disease
10.previous severe allergy to something
11.Pregnant, lactating, possibly pregnant or planning to become pregnant women
12.Malignant tumor
13.Patients considered as inadequate by the principal investigator
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Kishi |
Organization
Mitsui Memorial Hospital
Division name
Division of diabetes
Zip code
Address
1 Kanda Izumicho, Chiyoda-ku, Tokyo
TEL
03-3862-9111
m980287@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Kishi |
Organization
Mitsui Memorial Hospital
Division name
Division of diabetes
Zip code
Address
1 Kanda Izumicho, Chiyoda-ku, Tokyo
TEL
03-3862-9111
Homepage URL
m980287@gmail.com
Sponsor or person
Institute
Division of diabetes, Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
社会福祉法人三井記念病院(東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study: the relationship of T2DM with atherosclerosis.
Management information
Registered date
| 2014 | Year | 08 | Month | 05 | Day |
Last modified on
| 2020 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017172
