UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The role of Aldosterone in the pathogenesis of Diabetes.
Title of the study (Brief title)	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	Tatsuya Kondo
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Metabolic Medicine
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	Tatsuya Kondo
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Metabolic Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 03 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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