UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032453
Receipt number R000033703
Scientific Title Prospective study to detect a early marker of metabolic syndrome by development of a new monitoring system of nocturia and urine in IoT digital health device
Date of disclosure of the study information 2018/05/02
Last modified on 2022/05/05 11:30:11

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Basic information

Public title

Prospective study to detect a early marker of metabolic syndrome by development of a new monitoring system of nocturia and urine in IoT digital health device

Acronym

Prospective study of development of a new monitoring system of nocturia and urine in IoT digital health device

Scientific Title

Prospective study to detect a early marker of metabolic syndrome by development of a new monitoring system of nocturia and urine in IoT digital health device

Scientific Title:Acronym

Prospective study of development of a new monitoring system of nocturia and urine in IoT digital health device

Region

Japan


Condition

Condition

metabolic syndrome

Classification by specialty

Medicine in general Endocrinology and Metabolism Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To detect a early marker of metabolic syndrome by development of a new monitoring system of nocturia and urine in IoT digital health device

Basic objectives2

Others

Basic objectives -Others

Development of a new monitoring system of nocturia and urine in IoT digital health device

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Development of a new monitoring system of nocturia and urine in IoT digital health device

Key secondary outcomes

To detect a early marker of metabolic syndrome


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

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

medical digital device

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

metabolic syndrome patiens

Key exclusion criteria

heart failure

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Minoru
Middle name
Last name Miyazato

Organization

University of the Ryukyus

Division name

Department of Systems Physiology

Zip code

903-0215

Address

207 Uehara, Nishihara, Okinawa 903-0215, Japan

TEL

098-895-1186

Email

miyaz929@med.u-ryukyu.ac.jp


Public contact

Name of contact person

1st name Minoru
Middle name
Last name Miyazato

Organization

University of the Ryukyus

Division name

Department of Systems Physiology

Zip code

903-0215

Address

207 Uehara, Nishihara, Okinawa 903-0215, Japan

TEL

098-895-1186

Homepage URL


Email

miyaz929@med.u-ryukyu.ac.jp


Sponsor or person

Institute

University of the Ryukyus

Institute

Department

Personal name



Funding Source

Organization

University of the Ryukyus

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 the Ryukyus

Address

207 Uehara, Nishihara, Okinawa 903-0215, Japan

Tel

0988951186

Email

miyaz929@med.u-ryukyu.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

2018 Year 05 Month 02 Day


Related information

URL releasing protocol

http://ros-serv037.oops.jp/23728_ryuky/

Publication of results

Partially published


Result

URL related to results and publications

http://ros-serv037.oops.jp/23728_ryuky/

Number of participants that the trial has enrolled

61

Results

Night-time frequency did not change between baseline and 6 months in the intervention group but significantly worsened at 6 months in the non-intervention group, as compared to baseline.

Results date posted

2021 Year 05 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 12 Month 01 Day

Baseline Characteristics

normal volunteer
metabolic syndrome

Participant flow

normal volunteer
metabolic syndrome

Adverse events

none

Outcome measures

night-time urinary frequency

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2017 Year 10 Month 24 Day

Date of IRB

2017 Year 10 Month 24 Day

Anticipated trial start date

2018 Year 05 Month 02 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 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



Management information

Registered date

2018 Year 05 Month 02 Day

Last modified on

2022 Year 05 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033703


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name