UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017172