UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001085 |
|---|---|
| Receipt number | R000000874 |
| Scientific Title | Effect of insulin sensitizer treatment on carotid arterial elasticity |
| Date of disclosure of the study information | 2008/03/20 |
| Last modified on | 2008/03/18 23:21:23 |
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Basic information
Public title
Effect of insulin sensitizer treatment on carotid arterial elasticity
Acronym
PBS(Pioglitazone and Biguanide Study)
Scientific Title
Effect of insulin sensitizer treatment on carotid arterial elasticity
Scientific Title:Acronym
PBS(Pioglitazone and Biguanide Study)
Region
| Japan |
Condition
Condition
type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of insulin sensitizer traetment on arterial elasticity of diabetic subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
change of carotid arterial elasticity
Key secondary outcomes
changes of serum markers of atheroscrerosis,pulse wave velocity and carotid intima-media thickness
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pioglitazone 15mg daily
Interventions/Control_2
Metformin 750mg daily
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
| 35 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
type 2 diabetes
Key exclusion criteria
severe renal dysfunction
severe liver dysfunction
heart failure
history of lactic acidosis
severe retinopathy
severe vascular disease with urgent treatment
HbA1c over 9%
blood pressure over 180/100 mmHg
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitomo Oka |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Molecular Metabolism and Diabetes
Zip code
Address
Seiryou,1-1,Aobaku,Sendai
TEL
022-717-7611
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Ishigaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Molecular Metabolism and Diabetes
Zip code
Address
Seiryou,1-1,Aobaku,Sendai
TEL
022-717-7611
Homepage URL
yishigaki@mail.tains.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine,Division of Molecular Metabolism and Diabetes
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
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 03 | Month | 20 | 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
Date of protocol fixation
| 2007 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 03 | Month | 18 | Day |
Last modified on
| 2008 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000874
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
