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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003334
Receipt No. R000002324
Scientific Title Clinical investigation for soluble insulin receptor ectodomain in patients with diabetes, hypertension, dislipidemia, atherosclerosis and endocrine diseases
Date of disclosure of the study information 2010/03/15
Last modified on 2017/03/20

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Basic information
Public title Clinical investigation for soluble insulin receptor ectodomain in patients with diabetes, hypertension, dislipidemia, atherosclerosis and endocrine diseases
Acronym Clinical investigation for soluble insulin receptor ectodomain
Scientific Title Clinical investigation for soluble insulin receptor ectodomain in patients with diabetes, hypertension, dislipidemia, atherosclerosis and endocrine diseases
Scientific Title:Acronym 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
1st name
Middle name
Last name Eiichi Araki
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
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
1st name
Middle name
Last name Hiroyuki Motoshima
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 No longer recruiting
Date of protocol fixation
2007 Year 12 Month 10 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000002324

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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