UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between vascular endothelial function and oxidative stress during hypoglycemia induction by the insulin tolerance test
Title of the study (Brief title)	Relationship between vascular endothelial function and oxidative stress during hypoglycemia induction by the insulin tolerance test
Region	Japan

Condition
Condition	Adrenocortical insufficiency, pituitary insufficiency
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In addition to assessing the influence of hypoglycemia on vascular endothelial function, we examine factors such as oxidative stress and inflammatory cytokines.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of vascular endothelial function (RHI) before and after insulin tolerance test
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who satisfy all of the following criteria are included in this study. 1)Patients admitted to our hospital for diagnosis of adrenocortical hypofunction and hypopituitarism 2)Patients who need an insulin stress test for diagnosis 3)Male and female under age 65 when acquiring consent 4)Patients who agreed to participate in the study by written document
Key exclusion criteria	Patients falling under any of the following are excluded from this research. 1)Patients with a history of ischemic heart disease 2)Patients with a history of arrhythmia 3)Patients with a history of epilepsy 4)Other patients judged inappropriate by the attending physician
Target sample size	50

Research contact person
Name of lead principal investigator	Yosuke Okada
Organization	University of Occupational and Environmental Health, Japan, School of Medicine
Division name	The First Department of Internal Medicine
Address	1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
TEL	093-603-1611
Email	y-okada@med.uoeh-u.ac.jp

Public contact
Name of contact person	Keiichi Torimoto
Organization	University of Occupational and Environmental Health, Japan, School of Medicine
Division name	The First Department of Internal Medicine
Address	1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
TEL	093-603-1611
Homepage URL
Email	torimoto@med.uoeh-u.ac.jp

Sponsor
Institute	The First Department of Internal Medicine University of Occupational and Environmental Health, Japan, School of Medicine
Institute
Department

Funding Source
Organization	The First Department of Internal Medicine University of Occupational and Environmental Health, Japan, School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 08 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 08 Month 01 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Before and after the insulin tolerance test, the vascular endothelial function is evaluated using the RH-PAT method and a blood test is performed.

Management information
Registered date	2018 Year 07 Month 02 Day
Last modified on	2018 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037774