UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021777
Receipt number R000024906
Scientific Title Exercise adaptation and metabolic disorders
Date of disclosure of the study information 2016/04/04
Last modified on 2016/04/04 21:14:09

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Basic information

Public title

Exercise adaptation and metabolic disorders

Acronym

Exercise adaptation and metabolic disorders

Scientific Title

Exercise adaptation and metabolic disorders

Scientific Title:Acronym

Exercise adaptation and metabolic disorders

Region

Japan


Condition

Condition

Obesity, Hypertension, Diabetes, Dyslipidemia, Metabolic syndrome

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To investigate the effects of exercise training and diet on metabolic disorders.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Body weight. After 3 months of the intervention

Key secondary outcomes

Visceral fat, Body composition, Blood pressure, Glucose metabolism, Blood lipids, Cardio-respiratory fitness, Energy metabolism. After 3 months of the intervention


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Exercise group
300 min/wk in moderate intensity
12 weeks intervention

Interventions/Control_2

Diet group
Ideal body weight multiplied by 25kcal/day
12 weeks intervention

Interventions/Control_3

Intervention 1+2
12 weeks intervention

Interventions/Control_4

Control group
12 weeks intervention

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

Adults with risks for metabolic syndrome.

Key exclusion criteria

1) Type 1 diabetes
2) Secondary diabetes
3) Malfunction of glucose metabolism
4) Acute infectious disease
5) Proliferating retinopathy or fundus hemorrhage
6) liver or kidney disease
7) Ischemic heart disease
8) Severe bone disease
9) Diabetic gangrene
10) Autonomy neuropathic disorder
11) Doctor's instructions

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Tanaka

Organization

Fukuoka University

Division name

Fuculty of sports science

Zip code


Address

8-19-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, Japan

TEL

092-871-6631

Email

htanaka@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Tanaka

Organization

Fukuoka University

Division name

Fuculty of sports science

Zip code


Address

8-19-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, Japan

TEL

092-871-6631

Homepage URL


Email

htanaka@fukuoka-u.ac.jp


Sponsor or person

Institute

Fukuoka University

Institute

Department

Personal name



Funding Source

Organization

The ministry of Education, Culture, Sports, Science and Technology in Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 04 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

2006 Year 01 Month 09 Day

Date of IRB


Anticipated trial start date

2006 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 04 Day

Last modified on

2016 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024906


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name