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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003009
Receipt No. R000003644
Scientific Title the assessment of the inflammatory changes in abdominal aortic aneurysm by Pioglitazone
Date of disclosure of the study information 2010/01/10
Last modified on 2011/07/27

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Basic information
Public title the assessment of the inflammatory changes in abdominal aortic aneurysm by Pioglitazone
Acronym AIC test
Scientific Title the assessment of the inflammatory changes in abdominal aortic aneurysm by Pioglitazone
Scientific Title:Acronym AIC test
Region
Japan

Condition
Condition abdominal aortic aneurysm, arteriosclerosis obliterans
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 he objective of this study is to assess the effect of pioglitazone on inflammatory changes in abdominal aortic aneurysms (AAA) or ASO.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hsCRP, FACS analysis of Inflammatory cells, Inflammatory Cytokine analysis, RT-PCR analysis (Adiponectin, Leptin, TNF-alpha,IL-1beta,MCP-1, PAI-1, IL-8, IL-6, Resistin, Angiotensinogen, VEGF, MMP)
Key secondary outcomes blood examination
75g OGTT

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 pioglitazone 25 cases
Interventions/Control_2 statin 25cases
Interventions/Control_3 ARB 25 cases
Interventions/Control_4 non-treated 25ceses
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the patients who agreed this study
Key exclusion criteria 1,the patients who did not agree this study
2,infective aneurysm
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotsugu KUROBE
Organization IHBS, the university of TOKUSHIMA Graduate of School
Division name Cardiovascular surgery
Zip code
Address 3-18-15 Kuramoto-chou, Tokushima
TEL 088-633-7408
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu KUROBE
Organization IHBS, the university of TOKUSHIMA Graduate of School
Division name Cardiovascular surgery
Zip code
Address 3-18-15 Kuramoto-chou, Tokushima
TEL 088-633-7408
Homepage URL
Email hp@tokushima-cvs.info

Sponsor
Institute IHBS, the university of TOKUSHIMA Graduate of School
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JAPAN

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 徳島大学病院

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 10 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 Open public recruiting
Date of protocol fixation
2009 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 10 Day
Last modified on
2011 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003644

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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