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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001456
Receipt No. R000001760
Scientific Title The effect of angiotensin II receptor blocker (ARB) or thiazolidinedione (TZD) on adipocytokines and oxidative stress markers (Senri Study II)
Date of disclosure of the study information 2010/04/01
Last modified on 2010/08/09

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Basic information
Public title The effect of angiotensin II receptor blocker (ARB) or thiazolidinedione (TZD) on adipocytokines and oxidative stress markers (Senri Study II)
Acronym Senri Study II
Scientific Title The effect of angiotensin II receptor blocker (ARB) or thiazolidinedione (TZD) on adipocytokines and oxidative stress markers (Senri Study II)
Scientific Title:Acronym Senri Study II
Region
Japan

Condition
Condition Hypertensive and/or Diabetic patients
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the metabolic syndrome in the patients with hypertension and/or diabetes mellitus. We also examine the effect of ARB and/or TZD treatment with both diet and exercise therapy, on the circumference of waist, adipocytokines, and oxidative stress markers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of TBARS(Thiobarbituric acid reactive substances), highsensitive CRP, and Adiponectin at the completion of treatment form baseline
Key secondary outcomes Changes of waist circumference, glucose-lipid metabolic parameters, and blood pressure

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1)Hypertensive and/or diabetic patients who understand the study procedures using explanatory notes and have given written informed consent to participate in the study,
and,
2)Patients have not yet received candesartan and pioglitazone.
Key exclusion criteria 1)Contraindications of candesartan
2)Contraindications of Pioglitazone
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iichiro Shimomura, Tohru Funahashi
Organization Osaka University
Division name Metabolic medicine
Zip code
Address 2-2 B5, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3732
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ken Kishida
Organization Osaka University
Division name Metabolic medicine
Zip code
Address
TEL
Homepage URL
Email kkishida@imed2.med.osaka-u.ac.jp

Sponsor
Institute Department of Metabolic Medicine, Graduate School of Medicine, Osaka University
Institute
Department

Funding Source
Organization Department of Metabolic Medicine, Graduate School of Medicine, Osaka University
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
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
2010 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results 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
2008 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2008 Year 10 Month 26 Day
Last modified on
2010 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001760

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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