UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Performance evaluation of noninvasive lipid measurement device by fat load test
Title of the study (Brief title)	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	Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Department of Medical Management and Informatics
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	Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization	Hokkaido Information University
Division name	Health Information Science Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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