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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033791
Receipt No. R000038427
Scientific Title The change in organ specific insulin sensitivity after treatment of endocrine and metabolic disorder
Date of disclosure of the study information 2018/08/17
Last modified on 2020/02/17

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Basic information
Public title The change in organ specific insulin sensitivity after treatment of endocrine and metabolic disorder
Acronym The change in organ specific insulin sensitivity after treatment of endocrine and metabolic disorder
Scientific Title The change in organ specific insulin sensitivity after treatment of endocrine and metabolic disorder
Scientific Title:Acronym The change in organ specific insulin sensitivity after treatment of endocrine and metabolic disorder
Region
Japan

Condition
Condition endocrine and metabolic disorder
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects of treatment on insulin sensitivity.
Basic objectives2 Others
Basic objectives -Others To evaluate effects of treatment on insulin sensitivity.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes from baseline in organ specific insulin sensitivity and glucagon response during a euglycemic hyperinsulinemic clamp study
Key secondary outcomes 1Change from baseline in fasting plasma glucose level and glucose metabolism assessed with arginine tolerance test
2Change from baseline in body composition
3Change from baseline in vital sign
4Change from baseline in hormone levels of endocrine and metabolic disorder
5Change from baseline in medication
6Change from baseline in liver function
7Changes from baseline in lipid profile
8Changes from baseline in renal function and electrolyte balance
9Changes from baseline in hepatokine levels
10Changes from baseline in oxidative and non-oxidative glucose disposal, respiratory quotients, and energy expenditure

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 Patient who is diagnosed endocrinological disease
Patients whose content is obtained in written form
Key exclusion criteria Younger than 20 years old
Pregnant or lactating women
Patient in endocrinological emergency
Severe mental problems not suitable for the study
Inability to participate in the study as assessed by the investigators.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Toshinari
Middle name
Last name Takamura
Organization Kanazawa University Graduate School of Medical sciences
Division name Department of Endocrinology and metabolism
Zip code 920-8641
Address 13-1 Takara-machi Kanazawa Ishikawa
TEL 076-265-2234
Email ttakamura@m-kanazawa.jp

Public contact
Name of contact person
1st name Yumie
Middle name
Last name Takeshita
Organization Kanazawa university hospital
Division name Department of Endocrinology and metabolism
Zip code 9208641
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2234
Homepage URL
Email takeshita@m-kanazawa.jp

Sponsor
Institute Kanazawa university hospital
Department of Endocrinology and metabolism
Institute
Department

Funding Source
Organization None
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 kanazawa university
Address 13-1 Takara-machi
Tel 076-265-2110
Email rinri@adm.kanazawa-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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 17 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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 18 Day
Date of IRB
2018 Year 07 Month 18 Day
Anticipated trial start date
2018 Year 07 Month 19 Day
Last follow-up date
2028 Year 07 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2018 Year 08 Month 17 Day
Last modified on
2020 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038427

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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