UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014765
Receipt No. 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 2019/02/07

* 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 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
Email 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
Email m980287@gmail.com

Sponsor
Institute Division of diabetes, Mitsui Memorial Hospital
Institute
Department

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
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 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 No longer recruiting
Date of protocol fixation
2014 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
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
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017172

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.