UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exercise adaptation and metabolic disorders
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hiroaki Tanaka
Organization	Fukuoka University
Division name	Fuculty of sports science
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	Hiroaki Tanaka
Organization	Fukuoka University
Division name	Fuculty of sports science
Address	8-19-1 Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, Japan
TEL	092-871-6631
Homepage URL
Email	htanaka@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 01 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000024906