UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020946
Receipt number R000024049
Scientific Title Lifestyle modifications supported by regional health nurses reduce visceral fat and oxidative stress
Date of disclosure of the study information 2016/02/15
Last modified on 2021/02/15 15:35:30

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Basic information

Public title

Lifestyle modifications supported by regional health nurses reduce visceral fat and oxidative stress

Acronym

Visceral fat and oxidative stress

Scientific Title

Lifestyle modifications supported by regional health nurses reduce visceral fat and oxidative stress

Scientific Title:Acronym

Visceral fat and oxidative stress

Region

Japan


Condition

Condition

Normal subjects
Subjects with pre-metabolic syndrome
Subjects with metabolic syndrome

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A cross-sectional study is planned to elucidate the relationships between lifestyle, visceral fat, and arterial stiffness in subjects who are classified as normal, pre-metabolic or metabolic syndrome on annual special health checkups. Then, observational studies are planned to clarify whether lifestyle modifications supported by regional health nurses should improve visceral fat and arterial stiffness in subjects with pre-metabolic or metabolic syndrome. Especially in those with metabolic syndrome, oxidative stress will be examined before and after lifestyle modifications.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visceral fat after 6 month lifestyle modifications

Key secondary outcomes

Body weight
Waist circumference
Lifestyle
Central and peripheral blood pressure
Arterial stiffness
Oxidative stress


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

40 years-old <=

Age-upper limit

64 years-old >=

Gender

Male and Female

Key inclusion criteria

Normal subjects classified by an annual special health checkup.
Subjects with pre-metabolic syndrome detected by an annual special health checkup
Subjects with metabolic syndrome detected by an annual special health checkup

Key exclusion criteria

Diabetic or hypertensive patients, especially who take diabetic or hypertensive medications.
Patients with past history of cardiovascular disease
Patients who are suffering from acute or chronic inflammatory disease or malignant disease

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoichi Ohno

Organization

Saitama Medical University

Division name

Community Health Science Center

Zip code


Address

38 Moro-hongo, Moroyama-machi, Iruma-gun, Saitama Prefecture

TEL

049-276-1168

Email

yo1ohno@saitama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoichi Ohno

Organization

Saitama Medical University

Division name

Community Health Science Center

Zip code


Address

38 Moro-hongo, Moroyama-machi, Iruma-gun, Saitama Prefecture

TEL

049-276-1168

Homepage URL

http://www.saitama-med.ac.jp/chsc/index.html

Email

yo1ohno@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

埼玉医科大学
埼玉県市町村 保健センター


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 15 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 07 Month 24 Day

Date of IRB

2015 Year 04 Month 24 Day

Anticipated trial start date

2015 Year 09 Month 18 Day

Last follow-up date

2020 Year 02 Month 10 Day

Date of closure to data entry

2020 Year 10 Month 19 Day

Date trial data considered complete

2021 Year 10 Month 19 Day

Date analysis concluded

2021 Year 10 Month 19 Day


Other

Other related information

A cross-sectional study is planned to elucidate the relationships between lifestyle, visceral fat, and arterial stiffness in normal subjects, in subjects who were classified as normal, pre-metabolic and metabolic syndrome on annual special health checkups. Then, observational studies are planned to clarify whether lifestyle modifications supported by regional health nurses should improve visceral fat and arterial stiffness in subjects with pre-metabolic or metabolic syndrome. Especially in those with metabolic syndrome, oxidative stress will be examined before and after lifestyle modifications. Daily physical activity will be measured for several days during the 3- to 6- month period with lifestyle modifications in those with pre-metabolic or metabolic syndrome. The potential beneficial effects on cardio-metabolic parameters after lifestyle modifications will encourage the subjects themselves and health nurses to continue their health promotion.


Management information

Registered date

2016 Year 02 Month 09 Day

Last modified on

2021 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024049


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name