UMIN-CTR Clinical Trial

Basic information
Public title	To identify the presence of type 2 diabetes patients with elevated insulin clearance and clarify there clinical characteristics. determine factors that affect on blood insulin concentrations at steady state in hyperinsulinemic-euglycemic clamp test (insulin clearance).
Acronym	Identification of the presence of type 2 diabetes patients with elevated insulin clearance
Scientific Title	To identify the presence of type 2 diabetes patients with elevated insulin clearance and clarify there clinical characteristics.
Scientific Title:Acronym	Identification of the presence of type 2 diabetes patients with elevated insulin clearance
Region	Japan

Condition
Condition	Untreated type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify patients with elevated insulin clearance assessed by hyperinsulinemic-euglycemic clamp test.
Basic objectives2	Others
Basic objectives -Others	To clarify there clinical characteristics.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To identify patients with elevated insulin clearance assessed by hyperinsulinemic-euglycemic clamp test.
Key secondary outcomes	To clarify there clinical characteristics.

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	newly diagnosed and drug-treatment naive patient with type 2 diabetes mellitus
Key exclusion criteria	ketoacidosis, pregnancy, cancer, thyroid disease, adrenal tumor, renal failure, active infection, inflammatory disease, autoimmune disease, liver cirrhosis, Viral hepatitis, dementia, schizophrenia, and those who did not accept to have hyperinsulinemic-euglycemic clamp examination.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Noboru Middle name Last name Kurinami
Organization	Jinnouchi Hospital
Division name	Diabetes Care Center
Zip code	862-0976
Address	6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL	096-363-0011
Email	kurinami@jinnouchi.or.jp

Public contact
Name of contact person	1st name Noboru Middle name Last name Kurinami
Organization	Jinnouchi Hospital
Division name	Diabetes Care Center
Zip code	862-0976
Address	6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL	096-363-0011
Homepage URL
Email	kurinami@jinnouchi.or.jp

Sponsor
Institute	Jinnouchi Hospital
Institute
Department

Funding Source
Organization	Jinnouchi Hospital
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	Jinnouchi Hospital
Address	6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
Tel	096-363-0011
Email	hisyo@jinnouchi.or.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	陣内病院（熊本）

Other administrative information
Date of disclosure of the study information	2019 Year 04 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	101
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	Completed
Date of protocol fixation	2018 Year 03 Month 15 Day
Date of IRB	2018 Year 03 Month 26 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry	2021 Year 10 Month 13 Day
Date trial data considered complete	2021 Year 10 Month 13 Day
Date analysis concluded	2021 Year 10 Month 13 Day

Other
Other related information	Elevated insulin clearance evaluated by metabolic clearance rate of insulin (MCRI) in hyper insulinemic-euglicemic clamp test.

Management information
Registered date	2018 Year 03 Month 30 Day
Last modified on	2021 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036534