UMIN-CTR Clinical Trial

Basic information
Public title	Effects of regular aerobic exercise on arterial functions in obese men and its mechanisms
Acronym	Exercise and arterial functions in obesity
Scientific Title	Effects of regular aerobic exercise on arterial functions in obese men and its mechanisms
Scientific Title:Acronym	Exercise and arterial functions in obesity
Region	Japan

Condition
Condition	Obesity
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of regular aerobic exercise on arterial functions in obese men and its mechanisms
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	[Before and after the 12-week intervention] - Arterial functions (central hemodynamics)
Key secondary outcomes	[Before and after the 12-week intervention] - Insulin sensitivity - Glucose tolerance - Amino acids metabolism - Intramyocellular lipids - Extramyocellular lipids - Visceral fat area - Subcutaneous fat area - Body mass/composition - Bone strength - Circulating factors (e.g., cytokines) - Male sexual function - Peak oxygen uptake - Cognitive function - Sedentary behavior - Urinary biomarkers [Baseline and week 11-12] - Physical activity - Sleep habits

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group: aerobic exercise training (moderate intensity, 40-60 min per session, 3 sessions per week, 12 weeks)
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	30 years-old <=
Age-upper limit	64 years-old >=
Gender	Male
Key inclusion criteria	BMI range: 25.0-34.9 kg/m2
Key exclusion criteria	history of heart disease history of stroke Participation in an exercise program in the past year
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Seiji Middle name Last name Maeda
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences
Zip code	305-8577
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-8859
Email	maeda@taiiku.tsukuba.ac.jp

Public contact
Name of contact person	1st name Kanae Middle name Last name Myoenzono
Organization	University of Tsukuba
Division name	Doctoral Program in Sports Medicine
Zip code	305-8577
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-5990
Homepage URL
Email	s1730400@s.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science (JSPS)
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	Ethics committee university of tsukuba
Address	Tennodai, 1-1-1, Tsukuba, Ibaraki
Tel	029-853-2571
Email	hitorinnri@un.tsukuba.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	筑波大学総合研究棟D

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 09 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/31392903/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/31392903/
Number of participants that the trial has enrolled	21
Results	After the exercise intervention, weight, BMI, total body fat, abdominal visceral fat area, heart rate, and triglyceride were significantly decreased, and VO2peak was significantly elevated after the intervention. There were no significant differences in SBP, DBP, total cholesterol, HDL cholesterol, LDL cholesterol, and energy intake before and after the intervention. Moreover, there were no significant changes in baPWV,beta-stiffness index, and IMCL and EMCL contents after the exercise intervention.
Results date posted	2022 Year 01 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	21 overweight and obese men This study included 2 current smokers, and 7 subjects were taking anti-hypertensive, anti-diabetic, or anti-hyperlipidemic medication.
Participant flow	all subjects participated aerobic exercise training program
Adverse events	Non
Outcome measures	Body weight height visceral fat VO2peak resting arterial blood pressure resting HR blood biochemistry baPWV beta-stiffness index IMCL EMCL
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 05 Month 31 Day
Date of IRB	2017 Year 05 Month 29 Day
Anticipated trial start date	2017 Year 06 Month 10 Day
Last follow-up date	2017 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 06 Month 09 Day
Last modified on	2022 Year 01 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031744