UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003137
Receipt No. R000003801
Scientific Title Effect of high intensity exerice on insulin resistance.
Date of disclosure of the study information 2010/02/08
Last modified on 2010/02/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of high intensity exerice on insulin resistance.
Acronym Effect of high intensity exerice on insulin resistance.
Scientific Title Effect of high intensity exerice on insulin resistance.
Scientific Title:Acronym Effect of high intensity exerice on insulin resistance.
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the long-term improvement of high intensity exercise on insulin sensitivity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Insulin sensitivity
Key secondary outcomes Physical fitness
Prevalence of metabolic syndrome
Metabolic syndrome risk factor

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 A high-intensity training program consisted of stepping-exercise at 75% of heart rate reserve for 30 min per week, for 10 weeks.
Interventions/Control_2 A moderate intensity training program consisted of stepping-exercise at 50% of heart rate reserve for 45 min per week, for 10 weeks. Exercise volume is isocaloric to high intensity program.
Interventions/Control_3 A control group who are asked to maintain their previous daily living.
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
65 years-old >=
Gender Male
Key inclusion criteria Local officials in Sendai city determined metabolic syndrome preliminary group according to the JASSO creiteria in regular health check in 2009.

Metabolic syndrome preliminary group is defined as those who have central obesity (waist circumference >=85 cm) plus one of the other components following as:

1) dyslipidemia (triglyceride >=150 mg/dl or/and HDL cholesterol <40 mg/dl) or medication for dyslipidemia;

2) raised blood pressure (systolic blood pressure >=130 mmHg or/and diastolic blood pressure >=85 mmHg) or medication for hypertension;

3) raised fasting plasma glucose (>=110 mg/dl) or medication for diabetes.
Key exclusion criteria Those who are prohibited to do exercise by doctor

Orthopedic conditions prohibiting exercise

Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoichi Nagatomi
Organization Graduate School of Biomedical Engineering, Tohoku University
Division name Division of Biomedical Engineering for Health and Welfare
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, SENDAI MIYAGI, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, Tohoku University
Division name Department of Medicine and Science in Sports and Exercise
Zip code
Address
TEL 022-717-8589
Homepage URL
Email

Sponsor
Institute Graduate School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization Intelligent Cosmos Research Institute
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 08 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 No longer recruiting
Date of protocol fixation
2009 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2010 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 03 Day
Last modified on
2010 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003801

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.