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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Primary Aldosteronism | |
Classification by specialty |
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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 |
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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) |
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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 |
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Age-upper limit |
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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 |
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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 | ||||||
t-kondo@gpo.kumamoto-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |