UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005057 |
|---|---|
| Receipt number | 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 12:08:32 |
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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
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
Sponsor or person
Institute
Sanda City Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005995
