UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical investigation for soluble insulin receptor ectodomain in patients with diabetes, hypertension, dislipidemia, atherosclerosis and endocrine diseases
Title of the study (Brief title)	Clinical investigation for soluble insulin receptor ectodomain
Region	Japan

Condition
Condition	diabetes, hypertension, dislipidemia, atherosclerosis and endocrine diseases
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Cardiology Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the values of soluble insulin receptor ectodomain in patients with diabetes, hypertension, dislipidemia, atherosclerosis and endocrine diseases
Basic objectives2	Others
Basic objectives -Others	To determine whether values of soluble insulin receptor ectodomain serve as an index of glycemic control
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes of biomarkers during the treatment for individual disorders
Key secondary outcomes	blood glucose, glycated albumine, hemoglobin A1c

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	21 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Diabetes; blood glucose > 200mg/dl, Hypertension; BP > 135/85, Dislipidemia; HDL < 35 mg/dl, LDL > 140 mg/dl or TG >150mg/dl Atherosclerosis; clinical diagnosis for coronary artery disease or ASO Endocrine diseases; clinical diagnosis for endocrine diseases
Key exclusion criteria	persons who does not agree with informed concent for this study
Target sample size	300

Research contact person
Name of lead principal investigator	Eiichi Araki
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Metabolic Medicine
Address	1-1-1 Honjo, Chuo-Ku, Kumamoto, Japan
TEL	096-373-5169
Email	hmoto@kumamoto-u.ac.jp

Public contact
Name of contact person	Hiroyuki Motoshima
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Metabolic Medicine
Address	1-1-1 Honjo, Chuo-Ku, Kumamoto, Japan
TEL	096-373-5169
Homepage URL
Email	hmoto@kumamoto-u.ac.jp

Sponsor
Institute	Faculty of Life Sciences, Kumamoto University
Institute
Department

Funding Source
Organization	Tokushima Industrial Promotion Organization
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Tokushima University
Name of secondary funｄer(s)

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	2010 Year 03 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2007 Year 12 Month 10 Day
Anticipated trial start date	2008 Year 01 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We are investigating the alternation of indices for blood glucose control, levels of plasma insulin receptor ectodomain, and various clinical markers such BMI, lipid profile, markers for liver and renal function.

Management information
Registered date	2010 Year 03 Month 14 Day
Last modified on	2017 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002324