UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024737 |
|---|---|
| Receipt number | R000028360 |
| Scientific Title | To elucidate the role of PBMC mitochondria in obese subjects |
| Date of disclosure of the study information | 2016/11/10 |
| Last modified on | 2025/05/15 09:55:41 |
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Basic information
Public title
To elucidate the role of PBMC mitochondria in obese subjects
Acronym
BLOODMITO-OBESITY
Scientific Title
To elucidate the role of PBMC mitochondria in obese subjects
Scientific Title:Acronym
BLOODMITO-OBESITY
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that mitochondrial function in peripheral blood mononuclear cells (PBMC) may be impaired in obese subjects and lifestyle changes including diet and exercise may improve PBMC mitochondrial function in these patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PBMC mitochondrial function
Key secondary outcomes
Systemic oxidative stress
Systemic imflammatory markers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Instruction to improve lifestyle (e.g. diet and exercise) by health-care providers
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Obese subjects with more than 30 in BMI diagnosed in regular physical check-up
Key exclusion criteria
1.Subjects with active chronic inflammatory disease
2.Subjects who receive steroid or immunosuppressant drugs
3.Subjects who cannot give written informed consent
4.Subjects who are considered to be inappropriate for the study by principal investigator
Target sample size
77
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yokota |
Organization
Hokkaido University Hospital
Division name
Institute of Health Science Innovation for Medical Care
Zip code
060-8648
Address
Kita-14 Nishi-5, Kita-Ku, Sapporo, Japan
TEL
011-706-6001
t-yokota@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yokota |
Organization
Hokkaido University Hospital
Division name
Institute of Health Science Innovation for Medical Care
Zip code
060-8648
Address
Kita-14 Nishi-5, Kita-Ku, Sapporo, Japan
TEL
011-706-6001
Homepage URL
t-yokota@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (Japan)
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
Institutional Review Board of Faculty of Medicine and Graduate School of Medicine in Hokkaido University
Address
Kita-15 Nishi-7, Kita-Ku, Sapporo 060-8638, Japan
Tel
011-706-5003
shomu@med.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 10 | 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
| 2016 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Prospective study
2.A case-control study (Control group: healthy subjects with BMI<25) is also included only before intervention
Management information
Registered date
| 2016 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028360
