UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000441 |
|---|---|
| Receipt number | R000000537 |
| Scientific Title | Effects of pioglitazone on abdominal fat and reactive oxygen species in type 2 diabetes mellitus |
| Date of disclosure of the study information | 2006/07/05 |
| Last modified on | 2013/02/07 10:16:44 |
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Basic information
Public title
Effects of pioglitazone on abdominal fat and reactive oxygen species in type 2 diabetes mellitus
Acronym
ROSACT
Scientific Title
Effects of pioglitazone on abdominal fat and reactive oxygen species in type 2 diabetes mellitus
Scientific Title:Acronym
ROSACT
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare effects of pioglitazone or diet on abdominal fat and reactive oxygen species in drug naive type 2 diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
- Abdominal fat mass
- ROS (reactive oxygen species)
- Blood lipid parameters
Key secondary outcomes
- Glycemic control (OGTT, HbA1c)
- Cardiac function
- Aortic stiffness (Pulse wave velocity)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
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+diet
Interventions/Control_2
diet only
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
Type 2 diabetes mellitus (75g oral glucose tolerance test, ADA criteria) with
- male
- HbA1c<=7.5%, drug naive
- Waist circumference >=85cm
- Aged 30-69 years-old
- Gave written informed consent
Key exclusion criteria
- History of cerebro- and cardio-vascular disease
- History of congestive heart failure
- History of ketoacidosis or diabetic coma
- Moderate to severe liver dysfunction
- Moderate to severe renal dysfunction
- Moderate to severe infection, before and after operation, severe trauma
- Contraindication to antidiabetic medication
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Shimabukuro |
Organization
Faculty of Medicine, University of the Ryukyus, Okinawa, Japan
Division name
Second Department of Internal Medicine
Zip code
Address
207 Uehara, Nishihara, Okinawa 903-0215, Japan
TEL
098-895-1146
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Shimabukuro |
Organization
Faculty of Medicine, University of the Ryukyus, Okinawa, Japan
Division name
Second Department of Internal Medicine
Zip code
Address
207 Uehara, Nishihara, Okinawa 903-0215, Japan
TEL
098-895-1146
Homepage URL
mshimabukuro-ur@umin.ac.jp
Sponsor or person
Institute
Second Department of Internal Medicine,
Faculty of Medicine, University of the Ryukyus, Diabetes and Life-style related disease center, Tomishiro Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Second Department of Internal Medicine,
Faculty of Medicine, University of the Ryukyus, Diabetes and Life-style related disease center, Tomishiro Chuo Hospital
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
| 2006 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2005 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 07 | Month | 03 | Day |
Last modified on
| 2013 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000537
