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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031480
Receipt No. 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 2019/06/03

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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
Email 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
Email kyotorinsho@gmail.com

Sponsor
Institute Kyoto university hospital
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035937

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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