UMIN-CTR Clinical Trial

Basic information
Public title	Predictive value of carotid intima media thickness for cardiovascular disease in type 2 diabetic patients
Acronym	IMT and CVD
Scientific Title	Predictive value of carotid intima media thickness for cardiovascular disease in type 2 diabetic patients
Scientific Title:Acronym	IMT and CVD
Region	Japan

Condition
Condition	type 2 diabetic patients
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this retrospective study was to investigate the relationship between surrogate makerand cardiovascular events in Japanese type 2 diabetics.
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	predictive value ofcarotid IMT for CVD events
Key secondary outcomes	predictive value ofcarotid baPWV and ABI for CVD events

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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with type 2 diabetes who had their cIMT assessed at the outpatient clinic of Juntendo University Hospital between 2003 and 2005 were recruited in a cohort study. Patients fitting the following criteria were selected for this study: 1) 30-75 years of age, 2) negative history of CVD.
Key exclusion criteria	severe renal dysfunction, severe liver disease, malignancy
Target sample size	1500

Research contact person
Last name of lead principal investigator	1st name Tomoya Middle name Last name Mita
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolism and Endocrinology
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyo-ku
TEL	03-3813-3111
Email	tom-m@juntendo.ac.jp

Public contact
1st name of contact person	1st name Tomoya Middle name Last name Mita
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Metabolism and Endocrinology
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421
TEL	03-3813-3111
Homepage URL
Email	tom-m@juntendo.ac.jp

Sponsor
Institute	Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Juntendo University Graduate School of Medicine
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	Juntendo Ethics Committee
Address	Hongo2-1-1, Bunkyo, Tokyo
Tel	0338133111
Email	kenkyu5858@juntendo.ac.jp

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	2012 Year 10 Month 04 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2010 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 11 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	CV events were extracted from the medical records

Management information
Registered date	2012 Year 10 Month 04 Day
Last modified on	2019 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010609