UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001456 |
|---|---|
| Receipt number | 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 07:52:49 |
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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
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
kkishida@imed2.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001760
