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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Arteriosclerosis obliterans(ASO) patients with type 2 diabetes mellitus or impaired glucose tolerance | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 40 |
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Name of lead principal investigator |
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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 |
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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 | |
Institute | Sanda City Hospital |
Institute | |
Department |
Funding Source | |
Organization | Sanda City Hospital, Division of cardiology |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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IRB Contact (For public release) | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |