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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002196
Receipt No. R000002699
Scientific Title The analysis of effects on insulin resistance and atherosclerotic risk factors before and after the treatment in patients with primary aldosteronism (PA)
Date of disclosure of the study information 2009/07/14
Last modified on 2015/07/15

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Basic information
Public title The analysis of effects on insulin resistance and atherosclerotic risk factors before and after the treatment in patients with primary aldosteronism (PA)
Acronym The analysis of insulin resistance and risk factors alterations by the treatment of PA
Scientific Title The analysis of effects on insulin resistance and atherosclerotic risk factors before and after the treatment in patients with primary aldosteronism (PA)
Scientific Title:Acronym The analysis of insulin resistance and risk factors alterations by the treatment of PA
Region
Japan

Condition
Condition Primary aldosteronism
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the relationship between insulin resistance and inflammatory cytokines in patients with PA
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Insulin resistance
2) Inflamatory cytokine
3) markers of organ damage
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Surgical resection if PA is lateral adrenal tumor
Interventions/Control_2 Eplerenone administration if PA is bilateral hyperplasia
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Hypertension and
2) Aldosteron/renin ratio more than 20, and/or
3) Aldostreon/cortison rario more than 1.0 upon rapid ACTH loading test
Key exclusion criteria Glucocorticoid-remediable aldosteronism (GRA)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Kondo
Organization Faculty of Life Sciences, Kumamoto University
Division name Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Chuo-Ward, Kumamoto
TEL +81-96-373-5169
Email t-kondo@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Kondo
Organization Faculty of Life Sciences, Kumamoto University
Division name Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Chuo-Ward, Kumamoto
TEL +81-96-373-5169
Homepage URL
Email t-kondo@gpo.kumamoto-u.ac.jp

Sponsor
Institute Faculty of Life Sciences, Kumamoto University
Institute
Department

Funding Source
Organization Faculty of Life Sciences, Kumamoto University, Metabolic Medicine
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 熊本大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 14 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 Open public recruiting
Date of protocol fixation
2009 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2014 Year 07 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 07 Month 14 Day
Last modified on
2015 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002699

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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