UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002196 |
|---|---|
| Receipt number | 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 | 2022/11/29 15:50:45 |
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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
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
t-kondo@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 01 | Day |
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
| 2022 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002699
