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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017666
Receipt No. R000020477
Scientific Title The role of Aldosterone in the pathogenesis of Diabetes.
Date of disclosure of the study information 2015/05/25
Last modified on 2016/08/08

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Basic information
Public title The role of Aldosterone in the pathogenesis of Diabetes.
Acronym The role of Aldosterone in the pathogenesis of Diabetes.
Scientific Title The role of Aldosterone in the pathogenesis of Diabetes.
Scientific Title:Acronym The role of Aldosterone in the pathogenesis of Diabetes.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the mechanism of impaired glucose tolerance of Primary aldosteronism.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1)Insulin secretion
2)Inflamatory cytokine(IL-6,TNF)
3)Glucagon, GLP-1
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
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
(50mg Tablet 1T1* M)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Primary Aldosteronism
Key exclusion criteria Glucocorticoid-remediable aldosteronism
Target sample size 40

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, Chuoku, 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, Chuoku, 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
2015 Year 05 Month 25 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 Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 25 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 25 Day
Last modified on
2016 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020477

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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