UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048917 |
|---|---|
| Receipt number | R000055737 |
| Scientific Title | Verification of preventive and slowing effects of metabolic syndrome by Personal Health Record (PHR) intervention |
| Date of disclosure of the study information | 2022/09/12 |
| Last modified on | 2023/10/12 10:00:09 |
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Basic information
Public title
Verification of preventive and slowing effects of metabolic syndrome by Personal Health Record (PHR) intervention
Acronym
Verification of preventive and slowing effects of metabolic syndrome by Personal Health Record (PHR) intervention
Scientific Title
Verification of preventive and slowing effects of metabolic syndrome by Personal Health Record (PHR) intervention
Scientific Title:Acronym
Verification of preventive and slowing effects of metabolic syndrome by Personal Health Record (PHR) intervention
Region
| Japan |
Condition
Condition
Medical checkup
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct lifestyle guidance intervention by PHR and verify the effect of PHR on prevention and progression control of metabolic syndrome and control of diabetes incidence rate. It actually reduces the metabolic index by 30% at the start and at the end of the intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Metabolic Index compared before intervention or observation and after intervention or observation every 12 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Personal Health Record
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 who underwent a medical checkup at a research participating facility (Aisin Keikinzoku Co., Ltd.)
(2) Those who were positive for one or more of the diagnostic requirements for metabolic syndrome at a medical examination. One item is that the waist circumference is equal to or greater than the standard value (male: 85 cm, female: 90 cm).
(3) Persons aged between 20 and 65
(4) After receiving sufficient explanation regarding participation in this study, the patient's own freedom with sufficient understanding
Subjects who obtained written informed consent
Key exclusion criteria
(1) Persons diagnosed with diabetes
(2) Subjects who are receiving antidiabetic drugs, antihypertensive drugs, or drugs for treating dyslipidemia
(3) Subjects judged inappropriate for participation in this study by the attending physician for other reasons
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | kazuyuki |
| Middle name | |
| Last name | tobe |
Organization
University of Toyama
Division name
First Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama Prefecture
TEL
0764342281
hhhhisae@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Hisae |
| Middle name | |
| Last name | Honoki |
Organization
University of Toyama
Division name
First Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama Prefecture
TEL
0764342281
Homepage URL
hhhhisae@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Toyama Clinical Research Management Center
Address
2630 Sugitani, Toyama City, Toyama Prefecture
Tel
0764158857
rinri@adm.u-toyama.ac.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 | 09 | Month | 12 | 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
| 2020 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055737
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
