UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027559 |
|---|---|
| Receipt number | 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 08:48:38 |
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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
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
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031581
