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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name