UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003137 |
|---|---|
| Receipt number | 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 18:12:59 |
* 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
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
Sponsor or person
Institute
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003801
