UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048362 |
|---|---|
| Receipt number | R000055119 |
| Scientific Title | Research for analyzing the relationship between glucose levels and the pulse-wave augmentation index (Aindex ) , measured by a gyro sensor. |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2024/03/13 15:25:10 |
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Basic information
Public title
Research for analyzing the relationship between glucose levels and the
pulse-wave augmentation index (Aindex ) , measured by a gyro sensor.
Acronym
Research for analyzing the relationship between glucose levels and the
pulse-wave augmentation index (Aindex ) , measured by a gyro sensor.
Scientific Title
Research for analyzing the relationship between glucose levels and the
pulse-wave augmentation index (Aindex ) , measured by a gyro sensor.
Scientific Title:Acronym
Research for analyzing the relationship between glucose levels and the
pulse-wave augmentation index (Aindex ) , measured by a gyro sensor.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study was to analyze the relationship between blood glucose levels and the pulse-wave augmentation index (Aindex), index of the reflected wave in the artery, and provide a useful non-invasive method to estimate postprandial blood glucose levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Fasting and postprandial blood glucose levels by fingertip puncture
(2)Aindex (pulse wave characteristic)
Key secondary outcomes
(1)blood pressure test
(2)pulse rate test
(3)Physical examination (Height, weight, and BMI)
(4)Fingertip puncture for blood lipids (TC, HDL cholesterol, LDL cholesterol, TG, non-HDL, Glu)
(5)blood HbA1c test by fingertip puncture
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
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Age 30 to 69 years
2)a healthy person (Those who have no past history of chronic diseases or malignant tumors and are not under treatment for diseases or injuries.)
3)People who do not take drugs (Antihypertensives, hypnotics, antidepressants, blood, everything.)
4)Nonsmokers (> 5 yr)
5)Japanese
Key exclusion criteria
1)A person who is judged to be ineligible by the research representative.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | MINAMI |
Organization
Sunmarco clinic
Division name
-
Zip code
211-0004
Address
1-825-7, Sinmaruko, Nakahara-ku, Kawasaki
TEL
044-433-3005
shirom@sunmarcocl.com
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | AJIMA |
Organization
KYOCERA Corporation
Division name
Medical R&D Center
Zip code
220-0012
Address
3-7-1, Minatomirai, Nishi-ku, Yokohama
TEL
045-605-7090
Homepage URL
hiromi.ajima.xm@kyocera.jp
Sponsor or person
Institute
KYOCERA Corporation
Institute
Department
Personal name
Funding Source
Organization
KYOCERA Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Macromill, Inc.
Healthcare Systems Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.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
| 2022 | Year | 07 | Month | 20 | 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
220
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
| 2022 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of the present study was to analyze the relationship between blood glucose levels and the pulse-wave augmentation index (Aindex), index of the reflected wave in the artery.
Management information
Registered date
| 2022 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055119
