UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037643 |
|---|---|
| Receipt number | R000042928 |
| Scientific Title | Association of Sleep Duration with Cardio-metabolic Risk in Japanese : A Crosse-sectional Study |
| Date of disclosure of the study information | 2019/08/09 |
| Last modified on | 2023/09/15 11:00:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Association of Sleep Duration with Cardio-metabolic Risk Leading to Development of Atherosclerotic Cardiovascular Disease
Acronym
Sleep duration and cardio-metabolic risk
Scientific Title
Association of Sleep Duration with Cardio-metabolic Risk in Japanese
: A Crosse-sectional Study
Scientific Title:Acronym
Adequate sleep duration and cardio-metabolic risk
Region
| Japan |
Condition
Condition
Atherosclerotic cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the relationship between sleep duration and cardio-metabolic risk leading to atherosclerotic cardiovascular disease (ASCVD).
Basic objectives2
Others
Basic objectives -Others
We investigated the relationship between sleep duration and cardio-metabolic risk (abdominal obesity, serum lipids, and glycometabolism-related markers), leading to atherosclerotic cardiovascular disease (ASCVD).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy parameter was the relationship between sleep duration and cardio-metabolic risk: WC, HbA1c, Homeostatic model assessment insulin resistance (HOMA-IR), and serum non-high-density lipoprotein cholesterol (non-HDL-C) level.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Apparently healthy males who had undergone health check examinations at the Health Planning Center of Nihon University Hospital
Key exclusion criteria
The exclusion criteria included refusal to provide consent for participation in the study, current treatment of insulin therapy, positive history of atherosclerotic cardiovascular disease (ASCVD), absence of measurement of the serum lipid, fasting blood glucose, immunoreactive insulin, hemoglobin A1c (HbA1c), waist circumference (WC) and absence of a record of the average sleep duration per week.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital
Division name
Health Planning Center
Zip code
101-8309
Address
1-6 kandasurugadai, chiyodaku, Tokyo 101-8309, Japan
TEL
0332931711
tani.shigemasa@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigemasa |
| Middle name | |
| Last name | Tani |
Organization
Nihon University Hospital
Division name
Health Planning Center
Zip code
101-8309
Address
1-6 kandasurugadai, chiyodaku, Tokyo 101-8309, Japan
TEL
0332931711
Homepage URL
tani.shigemasa@nihon-u.ac.jp
Sponsor or person
Institute
Department of Health Planning Center, Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
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
Nihon University Hospital IRB
Address
1-6 kandasurugadai, chiyodaku, Tokyo 101-8309, Japan
Tel
0332931711
tani.shigemasa@nihon-u.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
日本大学病院 健診センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 09 | 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
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 08 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042928
