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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00155493
Other study ID # 9461700633
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received September 9, 2005
Last updated September 9, 2005
Start date January 2006
Est. completion date August 2006

Study information

Verified date June 2005
Source National Taiwan University Hospital
Contact Yueh-Bih Tang, M.D. Ph.D.
Phone 886-2-23123456
Email phoebe@ha.mc.ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

Periorbital rejuvenation has been an issue of great interest in plastic surgery. Adipose tissue plays an important role in the periorbital anatomy, and has a great impact on the aging process of the region. We believe age-related atrophy of the facial adipose tissue may be related to the decreased proliferation and differentiation capability of the preadipocytes (adipose precursor cells).


Description:

Understanding the age-related changes in periorbital adipose tissue is crucial for improving current rejuvenation techniques, or developing new ones. However, no such study has been reported in the literature.

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 pretarsal fat can be easily obtained from patients of various ages. This study is designed to objectively evaluate the age-related changes of the preadipocytes in human periorbital adipose tissue regarding their proliferation and differentiation capability.

The adipose samples taken during the surgery are sent to the lab immediately to separate the preadipocytes from the specimens. Their number is estimated under the microscope, and then the cells are cultured in vitro to evaluate their proliferation and differentiation capability. Proliferation is assessed by counting the number of preadipocyte everyday for 7 days, and differentiation is assessed by Glycerol-3-phosphate dehydrogenase (GPDH) assay.

A linear regression analysis is used to analyze correlations of the parameters with age. Moreover, by dividing the subjects who had their periorbital fat sampled during upper blepharoplasty operation into three age groups, the parameters are compared with ANOVA test. Therefore, the age-related changes of the proliferation and differentiation capability of the preadipocytes in human periorbital adipose tissue can be concluded.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- patients receiving lower blepharoplasty

Exclusion Criteria:

- patients who do not require fat removal

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training


Related Conditions & MeSH terms


Intervention

Procedure:
obtain surgical specimen for analysis


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary preadipocyte proportion in aged versus young group
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