UMIN-CTR Clinical Trial

Basic information
Public title	Establishment of organ specific insulin resistance indices in lifestyle-related diseases
Acronym	Euglycemic hyperinsulinemic clamp with stable isotope tracer infusion
Scientific Title	Establishment of organ specific insulin resistance indices in lifestyle-related diseases
Scientific Title:Acronym	Euglycemic hyperinsulinemic clamp with stable isotope tracer infusion
Region	Japan

Condition
Condition	Lifestyle-related diseases
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine organ specific insulin resistance in patient with lifestyle-related diseases and to establish simple insulin resistance indices.
Basic objectives2	Others
Basic objectives -Others	Validity
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Hepatic and peripheral tissue insulin resistance (hepatic glucose production and insulin-stimulated glucose disposal)
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Lifestyle-related diseases
Key exclusion criteria	1)Uncontrolled diabetes (HbA1c >10%) 2)Uncontrolled hypertension (systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg) 3)Pregnant or lactating women
Target sample size	20

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	920-8640
Address	13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL	076-265-2234
Email	ttakamura@m-kanazawa.jp

Public contact
Name of contact person	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	920-8640
Address	13-1 Takara-machi, Kanazawa, Ishikawa, Japan
TEL	076-265-2234
Homepage URL
Email	ttakamura@m-kanazawa.jp

Sponsor
Institute	Department of Endocrinology and Metabolism, Kanazawa University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	None
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	Innovative clinical research center
Address	13-1 takaramachi kanazawa Ishikawa
Tel	(076)265-2100
Email	t-isomu@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	2012 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	In progress
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	2010 Year 04 Month 09 Day
Date of IRB	2015 Year 02 Month 24 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No adverse event

Management information
Registered date	2012 Year 07 Month 06 Day
Last modified on	2022 Year 01 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009823