Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate the clinical efficacy of reduction of local fat on ipsilateral thigh through cryolipolysis (zeltiq) and controlateral thigh using by amplitude modulated frequency (conventional) method.
Cryolipolysis is a new concept to reduce fat since Zeltiq machine had been introduced several years ago. Several different trials such as high frequency, liposuction and chemical lipolysis to remove fat had been emerged and tried. Therefore, we would like to know the clinical efficacy of cryolipolysis through comparative experiment with former frequency method on each thigh on healthy Korean women.
Healthy premenopausal women who want to reduce the fat on thigh were included. 28 healthy volunteered women recruited for this study, 15 subjects among participated after interviewing, sampling their metabolic variables at initial visit. A total of 15 subjects would be investigated through food diary(24hour), femoral CT, anthropometric, metabolic variables at initial, 4th, 12th week. Histological examination under skin(initial and 12th week), questionnaire(4th, 12th week) for satisfaction, adverse events would be monitored during 3 month.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zeltiq | Active Comparator | Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine. |
|
| electrical stimulation | Sham Comparator | Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zeltiq | Device | Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cross Sectional Area of Fat in Both Thighs | reduction of fat amounts on both thighs measured by computerizing tomography | 4 weeks |
| Change of the Girths in Both Thighs | Mean differences of the circumferences of both thighs measured by inches | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks | The mean differences of the Cross-Sectional Areas of both Thighs between Baseline and 12 weeks | baseline and 12 weeks |
| Change of Girths in Both Thighs for 12 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyu Rae Lee, MD.PhD. | Director of Bariatric medicine, Family Medicine, Hong-Ik General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bariatric clinic/Family medicine, Hong-Ik General Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | KR Lee. Clinical Efficacy of Fat Reduction on the Thigh of Korean Women through CryolipolysisJ Obes Weight Loss Ther 2013, 3:6 |
| Label | URL |
|---|---|
| obesity \& weight loss therapy web site | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Not provided
Not provided
Not provided
Not provided
Not provided
Two arm, but same group. Electrical Stimulation on Rt thigh versus Zeltiq Application on Left thigh.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zeltiq on Left/ Electrical Stimulation on Right Thigh | Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine. zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics. Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency. electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Efficacy of Cryolipolysis |
| |||||||||||||
| Cryolipolysis on Thigh |
|
A total of 14 subjects were completed this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zeltiq on Left/Electrical Stimulation on Rt | Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine. zeltiq: Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics. Lipolysis had been done for 30 minutes on controlateral thigh fat through amplitude modulated frequency. electrical stimulation: Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cross Sectional Area of Fat in Both Thighs | reduction of fat amounts on both thighs measured by computerizing tomography | Cross sectional areas of both thighs at initial visit | Posted | Mean | Standard Deviation | millimeters squares | 4 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zeltiq | Cryolipolysis had been done for 1 hour on ipsilateral thigh fat through Zeltiq machine. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor dermatological compliaint | Skin and subcutaneous tissue disorders | Non-systematic Assessment | pain |
In the beginning, because this study has some drawback for small sample size , and secondly, although the novel treatment process for radio frequency method included more than 6 sessions, it was performed just at once as sham procedure in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kyu Rae LeeMD.PhD. | Gachon University of Medicine and Science | 8232-770-1215 | baria07@daum.net |
Not provided
| ID | Term |
|---|---|
| C564245 | Platelet Glycoprotein IV Deficiency |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| electrical stimulation | Device | Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency. |
|
|
Comparison of circumferences of both thighs for 12 weeks
| 12 weeks |
| Weight Change for 12 Weeks | Change in weight for 12 weeks | baseline and 12 weeks |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Change of the Girths in Both Thighs | Mean differences of the circumferences of both thighs measured by inches | Posted | Mean | Standard Deviation | inches | 4 weeks |
|
|
|
|
| Secondary | Change of the Fat Amount of Both Thighs Between Baseline and 12 Weeks | The mean differences of the Cross-Sectional Areas of both Thighs between Baseline and 12 weeks | Posted | Mean | Standard Deviation | mm^2 | baseline and 12 weeks |
|
|
|
| Secondary | Change of Girths in Both Thighs for 12 Weeks | Comparison of circumferences of both thighs for 12 weeks | Posted | Mean | Standard Deviation | inch | 12 weeks |
|
|
|
| Secondary | Weight Change for 12 Weeks | Change in weight for 12 weeks | Posted | Mean | Standard Deviation | Kg | baseline and 12 weeks |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 4 |
| 14 |
| EG001 | Electrical Stimulation | The radio frequency method was applied on right thigh (control side) as sham procedure for 30 minutes through 3000 Hz- amplitude modulated frequency at once. | 0 | 14 | 0 | 14 | 0 | 14 |
|
| Minor Dermatologic complaint | Skin and subcutaneous tissue disorders | Non-systematic Assessment | bruits |
|
| Minor generalized complaints | Gastrointestinal disorders | Non-systematic Assessment | blood tinged stool |
|
Not provided
Not provided