UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002527 |
|---|---|
| Receipt number | R000003087 |
| Scientific Title | Study for the significance of serum oxidative stress during treatment of diabetic melitus patients by pioglitazone |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2018/10/09 19:26:03 |
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Basic information
Public title
Study for the significance of serum oxidative stress during treatment of diabetic melitus patients by pioglitazone
Acronym
Study for serum oxidative stress during treatment of diabetic melitus
Scientific Title
Study for the significance of serum oxidative stress during treatment of diabetic melitus patients by pioglitazone
Scientific Title:Acronym
Study for serum oxidative stress during treatment of diabetic melitus
Region
| Japan |
Condition
Condition
DM
Classification by specialty
| Medicine in general | Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the clinical significance of oxidative stress level during treatment of DM patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stastically significant change of oxidative stress level during treatment of DM.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment by pioglitazone
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diabetic patients who are suitable for pioglitazone treatment.
Key exclusion criteria
1)pateints with cardiac dysfunction.
2)liver dysfuncion or renal dysfunction
3)pituitary galnd failure or adrenal failure
4)poor nutritional condition
5)people with heavy muscluar training
6)alcohol abuse
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kondoh |
Organization
Kyoto University Hospital
Division name
Dep. of Geriatric Med.
Zip code
Address
54 Kawaharacho Shogoin Sakyo-ku Kyoto city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Hospital
Division name
Dep. of Geriatric Med.
Zip code
Address
TEL
Homepage URL
hkondoh@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Dep. of Geriatric Med. Kyoto Univ. Hsp
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2013 | Year | 04 | Month | 01 | 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
| 2009 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 18 | Day |
Last modified on
| 2018 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003087
