UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000038427