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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000441
Receipt No. 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

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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
Email

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
Email mshimabukuro-ur@umin.ac.jp

Sponsor
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

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000537

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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