![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000034090 |
Receipt No. | R000038861 |
Scientific Title | Clinical investigation of Glucose Intolerance in Patients with Pheochromocytoma |
Date of disclosure of the study information | 2018/09/11 |
Last modified on | 2018/09/11 |
Basic information | ||
Public title | Clinical investigation of Glucose Intolerance in Patients with Pheochromocytoma | |
Acronym | Clinical investigation of Glucose Intolerance in Patients with Pheochromocytoma | |
Scientific Title | Clinical investigation of Glucose Intolerance in Patients with Pheochromocytoma | |
Scientific Title:Acronym | Clinical investigation of Glucose Intolerance in Patients with Pheochromocytoma | |
Region |
|
Condition | ||
Condition | pheochromocytoma | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the effects of pheochrmocytoma with regard to Glucose Intolerance. |
Basic objectives2 | Others |
Basic objectives -Others | To assess glycemic parameters in patients with pheochrmocytoma before and after surgery. |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Investigation of the association between the change of HOMA-beta and HOMA-R, and that of urinary levels of metanephrine/normetanephrine before and after surgery. |
Key secondary outcomes | Investigation of changes of fasting plasma glucose and HbA1c before and after surgery. |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | All individuals with pheochromocytoma who were admitted, diagnosed and who underwent surgery at Fukuoka University Chikushi Hospital (Fukuoka, Japan) from April 2014 to March 2018 | |||
Key exclusion criteria | none | |||
Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Fukuoka University Chikushi Hospital | ||||||
Division name | Department of Endocrinology and Diabetes Mellitus | ||||||
Zip code | |||||||
Address | 1-1-1, Zokumyoin, Chikushino, Fukuoka | ||||||
TEL | 092-921-1011 | ||||||
nihisak@fukuoka-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Fukuoka University Chikushi Hospital | ||||||
Division name | Department of Endocrinology and Diabetes Mellitus | ||||||
Zip code | |||||||
Address | 1-1-1, Zokumyoin, Chikushino, Fukuoka | ||||||
TEL | 092-921-1011 | ||||||
Homepage URL | |||||||
abe1ro@fukuoka-u.ac.jp |
Sponsor | |
Institute | Department of Endocrinology and Diabetes Mellitus, Fukuoka University Chikushi Hospital |
Institute | |
Department |
Funding Source | |
Organization | Supported by grants from MSD Corporation and Mitsubishi Tanabe Pharma Corporation. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
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 | 福岡大学筑紫病院(福岡県) |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information | We reveal the mechanism of glucose intolerance on pheochromocytoma by investigating glycemic parameters before and after surgery, and investigated the association between the change of parameters of HOMA-beta and HOMA-R, and that of urinary levels of metanephrine/normetanephrine before and after surgery. |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038861 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |