UMIN-CTR Clinical Trial

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
Email	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
Email	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
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IRB Contact (For public release)
Organization
Address
Tel
Email

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
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Results Delayed
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Baseline Characteristics
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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
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
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Research case data
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