UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000689 |
|---|---|
| Receipt number | R000000828 |
| Scientific Title | Effect of pioglitazone on renal function amelioration by measurement of cystatine C levels in the type 2 diabetic patients |
| Date of disclosure of the study information | 2008/03/31 |
| Last modified on | 2010/07/05 10:23:03 |
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Basic information
Public title
Effect of pioglitazone on renal function amelioration by measurement of cystatine C levels in the type 2 diabetic patients
Acronym
Effect of pioglitazone on renal function amelioration in the type 2 diabetic patients
Scientific Title
Effect of pioglitazone on renal function amelioration by measurement of cystatine C levels in the type 2 diabetic patients
Scientific Title:Acronym
Effect of pioglitazone on renal function amelioration in the type 2 diabetic patients
Region
| Japan |
Condition
Condition
Diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of renal protective effect by pioglitazone on the progression of type 2 diabetic nephropathy by measurement of cystatine C levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
cystatine C, creatinine clearance, albumin extcretion rate, creatinine
Key secondary outcomes
general biochemical tests, HOMA-R, fasting blood insulin, serum resistin, CRP, adiponectin, leptin levels
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pioglitazone 15-30mg/day
Interventions/Control_2
metformin 750mg/day
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
Male and Female
Key inclusion criteria
1)The patients who were diagnosed as type 2 diabetic nephropathy (stage II-IV)
2)Less than HbA1c 9.0 %
Key exclusion criteria
1)The patient that it is already taken thiazolidinedione.
2)The patient with serious liver functional dysfunction.
3)Gravida or the patient with pregnant likelihood.
4)It is the patient with irritation for thiazolidinedione.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | EITARO NAKASHIMA |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2142
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | EITARO NAKASHIMA |
Organization
Nagoya University Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2142
Homepage URL
eitaro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Diabetes,
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
NONE
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 03 | Month | 31 | 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 | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 04 | Month | 25 | Day |
Last modified on
| 2010 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000828
