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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038731
Receipt No. R000044123
Scientific Title Studies on non-invasive monitoring of lifestyle diseases
Date of disclosure of the study information 2019/12/02
Last modified on 2019/12/02

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Basic information
Public title Studies on non-invasive monitoring of lifestyle diseases
Acronym Studies on non-invasive monitoring of lifestyle diseases
Scientific Title Studies on non-invasive monitoring of lifestyle diseases
Scientific Title:Acronym Studies on non-invasive monitoring of lifestyle diseases
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to collect data on blood ingredients, blood flow, and blood pressure by non-intrusive measurements, and to compare them with blood sampling data for lifestyle diseases patients, life-style diseases spare group, and healthy Japanese men and women over 20 years of age
Basic objectives2 Others
Basic objectives -Others Comparison of non-invasive measurement data and blood sampling data
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Vital signs, Physical measurements, Blood test, Non-invasive measurements
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Japanese men and women aged 20 years or older at the time of the informed consent.
2)Subject whose values apply to reference value of life-style deseases by self-report
3)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria 1.Subject who is currently undergoing some kind of exercise, diet or medication.
2.Subject who has or had a history of either medicine or alcohol dependence syndrome.
3.Subject who has or had a history of mental illness (depression) or sleep disturbance.
4.Subject who is disease or history such severe diseases such as brain disease, malignant tumor, immune disease,liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases person.
5.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition.
6.Subject who carried out blood collection, component blood donation more than 400 mL within 200 mL or 3 months within one month going back from the date of consent acquisition.
7.Subject who is currently pregnant or lactating, or planning to get pregnant.
8.Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Ochitani
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code 108-0014
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 03-3431-1260
Email ochitani@huma-rd.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Ochitani
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code 108-0014
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 03-3431-1260
Homepage URL
Email ochitani@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization NTT DOCOMO, INC.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nihonbashi Sakura Clinic Research Ethics Committee
Address 1-9-2 Nihonbashi Kayabacho, Chuo-ku, Tokyo Inamura Building 5F
Tel 03-5575-5862
Email c-irb_ug@neues.co.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
2019 Year 12 Month 02 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
2019 Year 10 Month 31 Day
Date of IRB
2019 Year 11 Month 20 Day
Anticipated trial start date
2019 Year 12 Month 02 Day
Last follow-up date
2019 Year 12 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Crossing study

Management information
Registered date
2019 Year 11 Month 29 Day
Last modified on
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044123

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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