UMIN-CTR Clinical Trial

Basic information
Public title	The effect of the two exercise regimens on body composition in type 2 DM as a part of metabolic syndrome
Acronym	The effect of exercise on body composition in type 2 DM and metabolic syndrome
Scientific Title	The effect of the two exercise regimens on body composition in type 2 DM as a part of metabolic syndrome
Scientific Title:Acronym	The effect of exercise on body composition in type 2 DM and metabolic syndrome
Region	Japan

Condition
Condition	Metabolic syndrome and type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To see whether long-term training with relatively high intensity and long bout, may effectively affect energy balance within muscle, and have additive favorable changes in body composition, independent of weight loss.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body composition
Key secondary outcomes	Physical activity Body weight Plasama glucose concentration HbA1c

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	to receive relatively high-intensity and long bout exercise
Interventions/Control_2	to receive advices to promote physical activity
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Type 2 DM as a part of metabolic syndrome
Key exclusion criteria	Subjects with disability for exercise Already physically active subjects Subjects with low insulin secretory capacity
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Koichiro Azuma
Organization	School of Medicine, Keio University
Division name	Institute for Integrated Sports Medicine
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo160-8582, Japan
TEL
Email

Public contact
1st name of contact person	1st name Middle name Last name
Organization	School of Medicine, Keio University
Division name	Institute for Integrated Sports Medicine
Zip code
Address
TEL
Homepage URL
Email	azuma@sc.itc.keio.ac.jp

Sponsor
Institute	Institute for Integrated Sports Medicine, School of Medicine, Keio University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion Science
Organization
Division
Category of Funding Organization
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	2010 Year 10 Month 25 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	2010 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date	2010 Year 10 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	2010 Year 10 Month 25 Day
Last modified on	2015 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005308

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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