UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027559
Receipt No. R000031581
Scientific Title Performance evaluation of noninvasive lipid measurement device by fat load test
Date of disclosure of the study information 2017/05/31
Last modified on 2018/09/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Performance evaluation of noninvasive lipid measurement device by fat load test
Acronym Performance evaluation of noninvasive lipid measurement device by fat load test
Scientific Title Performance evaluation of noninvasive lipid measurement device by fat load test
Scientific Title:Acronym Performance evaluation of noninvasive lipid measurement device by fat load test
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is aimed to evaluate the performance of this device by comparing changes in blood triglyceride (TG) after fat load with the measurement results of existing blood test method and noninvasive lipid measurement device.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood triglyceride level by noninvasive measuring instrument
Blood triglyceride concentration by free glycerol elimination method
Key secondary outcomes Height, body weight, BMI, body fat percentage, blood pressure, pulse rate, blood flow, skin surface temperature,Ht,TC, LDL-C, HDL-C,casual blood glucose level,Apolipoprotein,Lipoprotein fraction,AST, ALT, r-GTP, ALP, LDH,BUN, CRE, UA, Alb, TP, T-Bil, CPK

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Test with fat load
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1.subjects whose TG is 50 mg / dl or more and less than 150 mg / dl, or 150 mg / dl or more.
Key exclusion criteria 1.Subjects using anticoagulants (such as warfarin), antiplatelet drugs (aspirin, clopidogrel, ticlopidine, cilostazol etc.), coagulation accelerators (calcium solution, thrombin, vitamin K, etc.).
2.Subjects with blood clotting disease (hemophilia, platelet asthenia, warfarin administration, liver failure, etc).
3.Subjects who may have allergic symptoms in dairy products.
4.Subjects who received physician treatment, medication, and life guiduance for obesity, dyslipidemia, diabetes.
5.Subjects suffering from severe cerebrovascular disease, heart disease, liver disease, kidney disease, gastrointestinal disease, endocrine metabolic disease, infection requiring notification.
6.Subjects using pacemakers and defibrillators.
7.Subjects who have injuries, atopic skin diseases, contact dermatitis, rashes, etc. on the skin of the upper arm.
8.Subjects with major surgical history relevant to the digestive system.
9.Subjects with unusually high, low blood pressure, abnormal hematological data, severe anemia.
10.Pre- or post-menopausal women complaining of obvious physical changes.
11.Excess smokers and regulars alcohol addicts or subjects with eating disordered lifestyle.
12.Subjects who donated a predetermined amount of blood in a given period.
13.Pregnant or lactating women or women who expect to be pregnant during this study.
14.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
15.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Medical Photonics, Co., Ltd.,
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
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
2017 Year 05 Month 31 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 Completed
Date of protocol fixation
2017 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2017 Year 06 Month 26 Day
Date of closure to data entry
2017 Year 07 Month 07 Day
Date trial data considered complete
2017 Year 07 Month 07 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 31 Day
Last modified on
2018 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031581

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.