UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026872 |
|---|---|
| Receipt number | R000030835 |
| Scientific Title | Study of epigenetic control mechanism on skeletal muscle metabolism with total knee arthroplasty. |
| Date of disclosure of the study information | 2017/04/05 |
| Last modified on | 2020/10/10 22:55:15 |
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Basic information
Public title
Study of epigenetic control mechanism on skeletal muscle metabolism with total knee arthroplasty.
Acronym
DNA methylation of the skeletal muscle-related gene with total knee arthroplasty.
Scientific Title
Study of epigenetic control mechanism on skeletal muscle metabolism with total knee arthroplasty.
Scientific Title:Acronym
DNA methylation of the skeletal muscle-related gene with total knee arthroplasty.
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Comparison of Skeletal muscle- related gene DNA methylation with TKA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The measure of skeletal muscle relation genes DNA methylation with osteoarthritis of knee patient.
Key secondary outcomes
The measure of Myokine with osteoarthritis of knee patient.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Total knee arthroplasty and rehabilitation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult person
The consent patient who is performed total knee arthroplasty cause of osteoarthritis of the knee
After receiving a full explanation upon participation in this study, through understanding, those documents consent free will of the person is obtained.
Key exclusion criteria
Patient of Cerebrovascular paralytic
Patient of the nerve paralysis
Patient of the nerve paralysis
The patient who it is difficult to judge participation in study for a mental disease
The other reason who principal investigator has determined to be inappropriate as a research subject.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Kimura |
Organization
Kansai Medical University Hospital
Division name
Health science
Zip code
573-1010
Address
573-1010 Hirakata Osaka Shinmachi 2-5-1
TEL
072-804-0101
drikimura@alles.or.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kamo |
Organization
Kansai Medical University Hospital
Division name
Health science
Zip code
573-1010
Address
573-1010 Hirakata Osaka Shinmachi 2-5-1
TEL
072-804-0101
Homepage URL
ryusei0819@gmail.com
Sponsor or person
Institute
Kansai Medical University Hospital
Health science center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University ethics committee
Address
573-1010 Hirakata Osaka Shinmachi 2-5-1
Tel
072-804-0101
rinri@hirakata.kmu.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
| 2017 | Year | 04 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6689537/pdf?cia-14-1433.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6689537/pdf?cia-14-1433.pdf
Number of participants that the trial has enrolled
9
Results
Body weight (P=0.046), total weight (P=0.027), and total fat mass (P=0.028) were significantly lower 5 months postoperatively than preoperatively. Five months post-surgery, the PDK4 gene was significantly more hypomethylated at eight sites in the CpG island, compared to pre-surgery. There was a significant correlation (r=0.88, P=0.02) between promoter region hypomethylation and weight loss. Total methylation rate and weight loss were significantly correlated (r=0.829, P=0.042).
Results date posted
| 2020 | Year | 10 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The enrolled patients attended the Department of Orthopedics Clinic at Kansai Medical University Hospital and underwent artificial knee arthroplasty between April 2017 and June 2017 for osteoarthritis and osteonecrosis. There were nine patients (10 knees), comprising five males and four females with an average age of 74.8 years and average body mass index (BMI) of 26.6 kg/m2 .
Participant flow
Body composition and knee extension muscle strength were measured before surgery and 5 months after surgery.
Rehabilitation was performed for 3 months after surgery. In the remaining 2 months, patients performed resistance training and aerobic exercise using an ergometer for 20 mins, twice a week. A biopsy of the vastus medialis was taken during surgery and 5 months post-surgery. Biopsy samples were treated with bisulfite after DNA extraction, and DNA methylation rate was calculated.
Adverse events
One male was treated postoperatively for cervical myelo-
pathy and two females experienced pain to a degree that
they could not complete the prescribed rehabilitation, so
six patients (seven knees; four males and two females) with an average age of 75.7 years and BMI of 25.1 kg/ 2
m were analyzed.
Outcome measures
We compared preoperative and 5month postoperative measures, including body composition, the methylation rate at each position in the CpG island of the muscle.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 07 | Month | 25 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2020 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030835
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