UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001948 |
|---|---|
| Receipt number | R000002372 |
| Scientific Title | The clinical study for the mechanism of pioglitazone-induced edema in patients with type 2 diabetes using a salt monitoring system |
| Date of disclosure of the study information | 2009/05/08 |
| Last modified on | 2009/05/08 16:19:17 |
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Basic information
Public title
The clinical study for the mechanism of pioglitazone-induced edema in patients with type 2 diabetes using a salt monitoring system
Acronym
The clinical study for the mechanism of pioglitazone-induced edema
Scientific Title
The clinical study for the mechanism of pioglitazone-induced edema in patients with type 2 diabetes using a salt monitoring system
Scientific Title:Acronym
The clinical study for the mechanism of pioglitazone-induced edema
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study to investigate the relationship between salt excretion and pioglitazone-induced edema
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of edema
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administration of pioglitazone (15mg/day)
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
Type 2 diabetic patients after obtaining written informed concent
Key exclusion criteria
1) Congestive heart failure or having a history of congestive heart failure
2) Severe ketosis, diabetic coma, or type 1 diabetes
3) Having a severe hepatic or renal dysfunction
4) Having a severe infection or injury, or during perioperative period
5) Having an allergic history of pioglitazone
6) Be pregnant or at risk of becoming pregnant
7) Receiving any diuretic medication
8) Evaluated as being inadequate by the physician-in-charge
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terauchi |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Graduate School of Medicine, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Grants for the Strategic Research Project (K18005, K19004) of Yokohama City University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 05 | Month | 08 | 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
Completed
Date of protocol fixation
| 2006 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 08 | Day |
Last modified on
| 2009 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002372
