UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003334
Receipt number 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 11:38:46

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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 or person

Institute

Faculty of Life Sciences, Kumamoto University

Institute

Department

Personal name



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

Value
https://center6.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