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Recruitment status
Unique ID issued by UMIN UMIN000002271
Receipt No. R000002777
Scientific Title Atherosclerosis Development in Metabolic Syndrome-the Ultrasound Study
Date of disclosure of the study information 2010/03/31
Last modified on 2009/07/30

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Basic information
Public title Atherosclerosis Development in Metabolic Syndrome-the Ultrasound Study
Acronym ADMIT study
Scientific Title Atherosclerosis Development in Metabolic Syndrome-the Ultrasound Study
Scientific Title:Acronym ADMIT study
Region
Japan

Condition
Condition Diabetic and/or Metabolic syndrome patients
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the diabetic and/or metabolic syndrome patients.We also examine the association the plaques formations and volumes of the atheroma with visceral fat, adipocytokines and oxidative stress markes.
Basic objectives2 Others
Basic objectives -Others this is an observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plaques formations and volumes of the atheroma,visceral fat, adipocytokines and oxidative stress markes
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diabetic and/or Metabolic syndrome patients who understand the study procedures using explanatory notes and have given written informed consent to participate in the study.
Key exclusion criteria 1. implanted a pacemaker
2. not suitable to this study (a doctor desides)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iichiro Shimomura, Tohru Funahashi
Organization Osaka University
Division name Metabolic Medicine
Zip code
Address 2-2 B5, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University
Division name Metabolic Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Osaka University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Osaka University
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

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 31 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
Date of protocol fixation
2009 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information we examine the association the plaques formations and volumes of the atheroma with visceral fat, adipocytokine and oxidative stress markers.

Management information
Registered date
2009 Year 07 Month 30 Day
Last modified on
2009 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002777


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