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

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 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


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

Value
https://center6.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