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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005057
Receipt No. R000005995
Scientific Title The effect of Pioglitazone in arteriosclerosis obliterans(ASO) patients with type 2 diabetes mellitus or impaired glucose tolerance
Date of disclosure of the study information 2011/02/14
Last modified on 2011/02/09

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Basic information
Public title The effect of Pioglitazone in arteriosclerosis obliterans(ASO) patients with type 2 diabetes mellitus or impaired glucose tolerance
Acronym The effect of Pioglitazone in arteriosclerosis obliterans(ASO) patients with type 2 diabetes mellitus or impaired glucose tolerance
Scientific Title The effect of Pioglitazone in arteriosclerosis obliterans(ASO) patients with type 2 diabetes mellitus or impaired glucose tolerance
Scientific Title:Acronym The effect of Pioglitazone in arteriosclerosis obliterans(ASO) patients with type 2 diabetes mellitus or impaired glucose tolerance
Region
Japan

Condition
Condition Arteriosclerosis obliterans(ASO) patients with type 2 diabetes mellitus or impaired glucose tolerance
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to confirm the effect of Pioglitazone (15-45mg) on the variety of biological marker, ultrasonography of artery of the lower limb, the change of pulse wave and both involvement in arteriosclerosis obliterans(ASO) patients with type 2 diabetes mellitus or impaired glucose tolerance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of Ankle Brachial Pressure Index(ABI), pulse wave velocity(PWV), Acceleration Time, Wave pattern, pulse wave, adiponectin, blood glucose level, lipid metabolism, blood pressure and BMI at 3month after administration of Pioglitazone
Key secondary outcomes Statistical involvement of primary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intake of Pioglitazone 30mg once a day. The dosage should be adjusted according to the patient's symptoms and tolerability by physician's discretion.
Interventions/Control_2 Standard treatment. The physician can't add and change oral blood glucose-lowering drugs and hypoglycemic drugs.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Arteriosclerosis obliterans(ASO) patients with type 2 diabetes mellitus or impaired glucose tolerance
Key exclusion criteria Patients with cardiac failure at present or in the past
Patients with severe renal dysfunction
Patients with severe liver dysfunction
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Ogasawara
Organization Sanda City Hospital
Division name Division of cardiology
Zip code
Address 3-1-1 Keyakidai, Sanda, Hyogo, Japan
TEL 079-565-8000
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Sanda City Hospital
Division name Division of cardiology
Zip code
Address 3-1-1 Keyakidai, Sanda, Hyogo, Japan
TEL 079-565-8000
Homepage URL
Email

Sponsor
Institute Sanda City Hospital
Institute
Department

Funding Source
Organization Sanda City Hospital, Division of cardiology
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 三田市民病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 14 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 Preinitiation
Date of protocol fixation
2011 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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

Management information
Registered date
2011 Year 02 Month 09 Day
Last modified on
2011 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005995

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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