UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034090 |
|---|---|
| Receipt number | 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 09:56:11 |
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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
| Japan |
Condition
Condition
pheochromocytoma
Classification by specialty
| Endocrinology and Metabolism |
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
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
| 1st name | |
| Middle name | |
| Last name | Kunihisa Kobayashi |
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
| 1st name | |
| Middle name | |
| Last name | Ichiro Abe |
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 or person
Institute
Department of Endocrinology and Diabetes Mellitus, Fukuoka University Chikushi Hospital
Institute
Department
Personal name
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
| 2018 | Year | 09 | Month | 11 | 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
| 2018 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 08 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 08 | Day |
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
| 2018 | Year | 09 | Month | 11 | Day |
Last modified on
| 2018 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
