UMIN-CTR Clinical Trial

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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