UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031480 |
|---|---|
| Receipt number | R000035937 |
| Scientific Title | The study about stress-related hormones in patients with disorder of glucose metabolism and endocrine. |
| Date of disclosure of the study information | 2018/02/26 |
| Last modified on | 2021/11/01 15:23:26 |
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Basic information
Public title
The study about stress-related hormones in patients with disorder of glucose metabolism and endocrine.
Acronym
The study about stress-related hormones.
Scientific Title
The study about stress-related hormones in patients with disorder of glucose metabolism and endocrine.
Scientific Title:Acronym
The study about stress-related hormones.
Region
| Japan |
Condition
Condition
Disorder of glucose metabolism
Endocrine disorder
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of stress-related hormones on metabolic function.
Basic objectives2
Others
Basic objectives -Others
Correlation between Oxytocin concentration and stress markers.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between oxytocin concentration and stress markers.
Key secondary outcomes
Correlation between oxytocin and some other stress-related hormones.
Correlation between oxytocin and some metabolic parameters.
Evaluation of oxytocin in the patients with endocrine disease.
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
Fasting glucose level>126mg/dl or glucose level>200mg/dl or HbA1c>6.5%.
With diabetic retinopathy.
Patients treated by antidiabetes agent.
LDL>140mg/dl or HDL<40mg/dl or TG>150mg/dl.
Patients treated by agent for hyperlipidemia .
BMI>25
Endocrine disease or possibility of the disease
Key exclusion criteria
Pregnant female
Disease in the oral cavity
Disturbance of salivary secretion
Patient taking antidepressants
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobuya |
| Middle name | |
| Last name | Inagaki |
Organization
Kyoto university hospital
Division name
Department of diabetes, endocrinology and nutrition
Zip code
6068501
Address
54 kawara-cho, shougoin, sakyou-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3111
kyotorinsho@gmail.com
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Kawashima |
Organization
Kyoto university hospital
Division name
Department of diabetes, endocrinology and nutrition
Zip code
6068501
Address
54 kawara-cho, shougoin, sakyou-ku, Kyoto city, Kyoto, Japan
TEL
075-751-3560
Homepage URL
kyotorinsho@gmail.com
Sponsor or person
Institute
Kyoto university hospital
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant
Center of Innovation Science and Technology based Radical Innovation and Entrepreneurship Program
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university graduate school and faculty of medicine, Kyoto university hospital Ethics committe
Address
54 kawara-cho, shougoin, sakyou-ku, Kyoto city, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
follow up period : 2 years after registration
Management information
Registered date
| 2018 | Year | 02 | Month | 26 | Day |
Last modified on
| 2021 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035937
| Research Plan | |
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| 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 |
