UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028067 |
|---|---|
| Receipt number | R000032135 |
| Scientific Title | Longitudinl association between sleep disordered breathing and metabolic risk factors |
| Date of disclosure of the study information | 2017/07/05 |
| Last modified on | 2020/04/01 18:19:34 |
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Basic information
Public title
Longitudinl association between sleep disordered breathing and metabolic risk factors
Acronym
sleep apnea and metabolic risk factors
Scientific Title
Longitudinl association between sleep disordered breathing and metabolic risk factors
Scientific Title:Acronym
sleep apnea and metabolic risk factors
Region
| Japan |
Condition
Condition
Obesity diabetes hypertension
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the presence of sleep disordered-breathing associates with incidental hypertension and diabetes independently of BMI
Basic objectives2
Others
Basic objectives -Others
To clarify the deterioration of sleep disorderd breathing in subjects with AHI 5-20.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of diabetes, hypertension, and the progression of sleep-apnea
Key secondary outcomes
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
middle-aged Japanese men and women who voluntarily received a test for polysomnography at health check-ups.
Key exclusion criteria
those who had measurements on polysomnography less than 5 hours.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Oka Rie |
Organization
Kanazawa University Hospital
Division name
Cardiovascular and Internal Medicine
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2264
ririoka@goo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Oka Rie |
Organization
Kanazawa University Hospital
Division name
Cardiovascular and Internal Medicine
Zip code
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2264
Homepage URL
ririoka@goo.jp
Sponsor or person
Institute
Hokuriku Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokuriku CentrlHhospital
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
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 | 07 | Month | 05 | 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
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Historical cohort study using data of medical health check-ups
Management information
Registered date
| 2017 | Year | 07 | Month | 04 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032135
