UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022180 |
|---|---|
| Receipt number | R000025555 |
| Scientific Title | Hormonal analysis on Cushing syndrome before and after treatment |
| Date of disclosure of the study information | 2016/05/10 |
| Last modified on | 2021/11/05 09:08:26 |
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Basic information
Public title
Hormonal analysis on Cushing syndrome before and after treatment
Acronym
Hormonal analysis on Cushing syndrome
Scientific Title
Hormonal analysis on Cushing syndrome before and after treatment
Scientific Title:Acronym
Hormonal analysis on Cushing syndrome
Region
| Japan |
Condition
Condition
Cushing syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Cushing syndrome, glucocorticoid excess cause hyperphagia, obesity and impaired glucose tolerance, but these mechanisms are not clarified. Agouti-related protein (AgRP, an orexigenic neuropeptide) and thioredoxin interacting protein (TXNIP, a diabetes associated factor) are induced by glucocorticoid, however, the role of these molecule are unknown in Cushing syndrome. We will analyze whether circulating AgRP, TXNIP or other hormones are changed compare before and after operation of Cushing syndrome.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether circulating AgRP, TXNIP or other hormones are changed compare before and after operation of Cushing syndrome
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Cushing syndrome patients who are caused by unilateral adrenocortical adenoma and treated with surgery at Kochi Medical School hospital
Key exclusion criteria
None
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | MITSURU |
| Middle name | |
| Last name | NISHIYAMA |
Organization
Kochi Medical School, Kochi University
Division name
Department of Endocrinology, Metabolism & Nephrology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku city, Kochi 783-8505, Japan
TEL
088-880-2343
nisiyamm@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | MITSURU |
| Middle name | |
| Last name | NISHIYAMA |
Organization
Kochi Medical School, Kochi University
Division name
Department of Endocrinology, Metabolism & Nephrology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku city, Kochi 783-8505, Japan
TEL
088-880-2343
Homepage URL
nisiyamm@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Others
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
Kochi University Ethics Committee
Address
1-5-2, Akebono-cho, Kochi city, Kochi 783-8505
Tel
088-844-0111
rinri21@kochi-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 10 | 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
| 2013 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
If circulating AgRP and TXNIP are reduced after successful operation of Cushing syndrome, AgRP and TXNIP may be associated with glucocorticoid induced hyperphagia, obesity and impaired glucose intolerance.
We collect all the patients in line with criteria for selection who consulted our hospital from September 2013 to March 2021.
Management information
Registered date
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2021 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025555
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
