AgingPhase 1NCT00154453
Age-Related Changes in Myosin Heavy Chain Composition in Human Orbicularis Oculi Muscle
A Phase 1 study testing obtain surgical specimen for analysis in people with Aging, run by National Taiwan University Hospital.
Trial summary
Orbicularis oculi muscle is a key structure in the peri-orbital anatomy and is responsible for the major changes of aging in this area. Peri-orbital rejuvenation has been an issue of great interest in plastic surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- obtain surgical specimen for analysis
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Aug 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients receiving blepharoplasty
Who cannot join
- -
About this study
Orbicularis oculi muscle is a key structure in the peri-orbital anatomy and is responsible for the major changes of aging in this area. Peri-orbital rejuvenation has been an issue of great interest in plastic surgery. We believe that understanding the age-related histomorphometric changes in orbicularis oculi muscle is important for improving the current rejuvenation techniques or developing the new ones. Nevertheless, a study focusing on this topic has never been performed before, simply because it is difficult and dangerous to perform needle biopsy on orbicularis oculi muscle.
Read the detailed description
Hundreds of people came to our hospital requesting upper blepharoplasty every year. Taking advantage of the discarded soft tissue in the blepharoplasty surgery, samples of bilateral orbicularis oculi muscle can be easily obtained from patients of various ages. This study is designed to objectively evaluate the age-related changes in human orbicularis oculi muscle by analyzing the composition of isoforms of myosin heavy chain (MHC), which is the predominant protein in skeletal muscle. MHC isoforms exist in different types of muscle fibers, and determines the maximum contraction speed of the muscle fiber. Therefore, The composition of MHC isoforms represents the composition of different types of muscle fiber.
These muscle specimens are stored with liquid nitrogen right after surgery. In the lab, the specimens are sectioned to 40μm in thickness, and soaked in special buffer solution. After electrophoresis and staining, bands of different types of MHC can be visualized. The gel is scanned and processed with an image analysis system. The density of each band can be determined, and the ratio of the different types of MHC can be calculated.
By dividing the subjects who had their orbicularis oculi muscle sampled during upper blepharoplasty operation into age groups of 20, 30, 40, 50, 60 and 70 years, these MHC subtypes composition ratios can be compared among the different groups. Therefore, the age-related changes of the composition of different muscle types can be concluded.
- Conditions
- Aging
- Being tested
- obtain surgical specimen for analysis
- Keywords
- Aging, Orbicularis oculi, Blepharoplasty, Myosin heavy chain (MHC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obtain surgical specimen for analysisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiation capability of preadipocyte
Secondary outcomes (1)
Proliferation capability of preadipocyte
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yueh-Bih Tang, M.D. Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154453
- Sponsor's protocol ID
- 9261701166
- Status last verified
- Oct 2003
- First submitted
- 9 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Changes in Myosin Heavy Chain Composition in Human Orbicularis Oculi Muscle
- ClinicalTrials.gov ID
- NCT00154453
- Acronym / sponsor ID
- 9261701166
- Conditions
- Aging
- Keywords
- Aging, Orbicularis oculi, Blepharoplasty, Myosin heavy chain (MHC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Aug 2004
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Orbicularis oculi muscle is a key structure in the peri-orbital anatomy and is responsible for the major changes of aging in this area. Peri-orbital rejuvenation has been an issue of great interest in plastic surgery. We believe that understanding the age-related histomorphometric changes in orbicularis oculi muscle is important for improving the current rejuvenation techniques or developing the new ones. Nevertheless, a study focusing on this topic has never been performed before, simply because it is difficult and dangerous to perform needle biopsy on orbicularis oculi muscle.
Detailed description
Hundreds of people came to our hospital requesting upper blepharoplasty every year. Taking advantage of the discarded soft tissue in the blepharoplasty surgery, samples of bilateral orbicularis oculi muscle can be easily obtained from patients of various ages. This study is designed to objectively evaluate the age-related changes in human orbicularis oculi muscle by analyzing the composition of isoforms of myosin heavy chain (MHC), which is the predominant protein in skeletal muscle. MHC isoforms exist in different types of muscle fibers, and determines the maximum contraction speed of the muscle fiber. Therefore, The composition of MHC isoforms represents the composition of different types of muscle fiber.
These muscle specimens are stored with liquid nitrogen right after surgery. In the lab, the specimens are sectioned to 40μm in thickness, and soaked in special buffer solution. After electrophoresis and staining, bands of different types of MHC can be visualized. The gel is scanned and processed with an image analysis system. The density of each band can be determined, and the ratio of the different types of MHC can be calculated.
By dividing the subjects who had their orbicularis oculi muscle sampled during upper blepharoplasty operation into age groups of 20, 30, 40, 50, 60 and 70 years, these MHC subtypes composition ratios can be compared among the different groups. Therefore, the age-related changes of the composition of different muscle types can be concluded.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients receiving blepharoplasty
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| obtain surgical specimen for analysis | Procedure or surgery | – |
Primary outcome
Differentiation capability of preadipocyte
1 secondary outcome
Proliferation capability of preadipocyte
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yueh-Bih Tang, M.D. Ph.D. principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing obtain surgical specimen for analysis in people with Aging, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentiation capability of preadipocyte. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2005.