UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051129 |
|---|---|
| Receipt number | R000054197 |
| Scientific Title | Elucidation of the mechanism of improvement of ectopic fat accumulation and insulin resistance by focusing on exercise intensity |
| Date of disclosure of the study information | 2023/05/22 |
| Last modified on | 2023/05/22 21:54:03 |
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Basic information
Public title
Role of exercise intensity on muscle metabolisms.
Acronym
Role of exercise intensity on muscle metabolisms.
Scientific Title
Elucidation of the mechanism of improvement of ectopic fat accumulation and insulin resistance by focusing on exercise intensity
Scientific Title:Acronym
Exercise intensity and insulin resisrance/intramyocellular lipid
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the role of exercise intensity on intramyocelluar lipid level and insulin sensitivity when energy expenditure is equalized.
Basic objectives2
Others
Basic objectives -Others
To clarify the role of exercise intensity on physiological parameters.
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in intramyocellular lipids and insulin sensitivity by exercise intervention.
Key secondary outcomes
intrahepatic lipid content
fasting blood glucose
free fatty acid
plasma insulin
serum adiponectin
muscle and serum lipid composition
muscle gene expression levels
body weight
body fat Percentage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Low intensity exercise (40% VO2 peak) with ergometer for 5 consecutive days
Interventions/Control_2
Vigorous intensity exercise (60% VO2 peak for day 1, 65% for day 2, and 70% for days 3-5) with ergometer
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
| Not applicable |
Gender
Male
Key inclusion criteria
Japanese men, aged 20 years and older, BMI over 23, fitness habits less than one time per week, no medical treatment.
On the screening session, blood samples were taken after an overnight fast to measure triglycerides (TG), HDL cholesterol (HDL-C), and fasting plasma glucose (FPG). Arterial blood pressure (BP), height, and weight were also measured. Based on the Japanese definition of metabolic syndrome, three cardiovascular metabolic risk factors were defined as hyperglycemia (FPG 110 mg/dL or higher), dyslipidemia (TG above 150 mg/dL and/or HDL-C less than 40 mg/dL), and hypertension (BP of 130/85 mm Hg or higher ) and have at least one of these and insulin resistance HOMA-IR 1.6 or higher (abnormal insulin sensitivity in Japan)
Key exclusion criteria
(1) People with diabetes mellitus.
(2)Excessive and habitual drinkers.
(3) Serious liver dysfunction
(4)Persons with serious renal disease
(5)Persons with cardiovascular diseases such as arrhythmic disease or ischemic heart disease.
(6)Persons with serious pancreatic diseases.
(7) Patients with cancer.
(8) Those infected with hepatitis B virus or hepatitis C virus.
(9) Patients with serious infectious diseases or serious trauma.
(10) Patients before or after surgery.
(10) Patients with inflammatory bowel disease, colorectal ulcer, local bowel obstruction, or predisposition to bowel obstruction.
(11) Patients who are allergic to local anesthesia.
(12) Persons who do not meet the safety requirements for MRI experiments.
(13) Subjects who are deemed inappropriate by the examining physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Tamura |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
113-8431
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan.
TEL
03-3813-3111
ys-tamur@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | FUNAYAMA |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism & Endocrinology
Zip code
113-8431
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan.
TEL
03-3813-3111
Homepage URL
tfunaya@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine Department of Metabolism & Endocrinology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University school of medicine Ethics Committee
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan Zip; 113-8421
Tel
03-5802-1020
rinri@juntendo.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
順天堂医院(東京都)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 22 | 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
20
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
| 2013 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 22 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054197
