UMIN-CTR Clinical Trial

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	150
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	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 12 Day
Date of closure to data entry	2019 Year 12 Month 24 Day
Date trial data considered complete	2019 Year 12 Month 25 Day
Date analysis concluded

Other
Other related information	Crossing study

Management information
Registered date	2019 Year 11 Month 29 Day
Last modified on	2020 Year 01 Month 09 Day

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