UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033244 |
|---|---|
| Receipt number | R000037774 |
| Scientific Title | Relationship between vascular endothelial function and oxidative stress during hypoglycemia induction by the insulin tolerance test |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2018/06/23 19:34:06 |
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Basic information
Public title
Relationship between vascular endothelial function and oxidative stress during hypoglycemia induction by the insulin tolerance test
Acronym
Relationship between vascular endothelial function and oxidative stress during hypoglycemia induction by the insulin tolerance test
Scientific Title
Relationship between vascular endothelial function and oxidative stress during hypoglycemia induction by the insulin tolerance test
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yosuke Okada |
Organization
University of Occupational and Environmental Health, Japan, School of Medicine
Division name
The First Department of Internal Medicine
Zip code
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
TEL
093-603-1611
y-okada@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Torimoto |
Organization
University of Occupational and Environmental Health, Japan, School of Medicine
Division name
The First Department of Internal Medicine
Zip code
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
TEL
093-603-1611
Homepage URL
torimoto@med.uoeh-u.ac.jp
Sponsor or person
Institute
The First Department of Internal Medicine
University of Occupational and Environmental Health, Japan, School of Medicine
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 01 | 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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037774
| 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 |
