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
Not provided
Not provided
Not provided
The aim of this study is to analyze the effects of a single session of cryolipolysis on localized adiposity on women's abdomen. This is a randomized controlled clinical trial that will include 28 women who will be randomly allocated into two groups: Control Group or Intervention Group. The following assessments will be performed in both groups: ultrasonography and body composition at baseline and 30, 60 and 90 days after randomization and blood analysis at baseline and 15 and 30 days after randomization. The expected main result at the end of this study is the reduction of the local subcutaneous fat tissue.
Cryolipolysis is a non - invasive method for localized fat reduction wich uses low temperatures to induce an apoptotic and inflammatory response and consequent adipocyte death in the treated area. Although the practice of this technique has been increasing, there are some gaps in the literature about the exact mechanism of action and only a few randomized clinical trials that proves its effectiveness and safety. Then, the aim of this study is to analyse the effects of cryolipolysis on localized fat on women's abdomen. This is a randomized controlled clinical trial that will include 28 women who will be randomized to Control Group (CG) or Intervention Group (IG). The CG will perform the Evaluation Protocol with the following assessments: ultrasonography, thermographic analysis, blood analysis, bioimpedance and measurement of skinfold and abdominal circumference. The IG will receive a single cryolipolysis's session on lower abdomen and the Evaluation Protocol. The follow up for both groups is 90 days. Expected main result at the end of the study is the reduction of the local subcutaneous fat tissue.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Subjects will only receive the Evaluation Protocol and will be followed for 90 days. | |
| Intervention Group | Active Comparator | A single 50 minutes session of cold exposure with a cryolipolysis device. The parameters will be: temperature -10°C and vacuum between 60 Kpas (at beginning) and 40 Kpas (until the end). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryolipolysis | Other | First, the demarcation of the lower abdomen area at the same landmarks of the ultrasonography will be done. Secondly, the patient will be positioned on the stretcher in the supine position with a 45 ° elevation of the trunk. In this position, to protect the region to be treated, a glycerine antifreeze membrane will be placed. The treatment parameters will be: temperature of -10 ° C, treatment time of 50 minutes (first 3 minutes of heating at 42°C) and moderate vacuum pressure (60 - 40 Kpas). The applicator will be chosen according to the size of the area of each subject and positioned in the target region. At the end the skinfold will be released automatically, the antifreeze membrane removed and a manual massage will be carried out for five minutes to stimulate local blood reperfusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Subcutaneous fat layer | Subcutaneous fat layer changes measured by ultrasonography and skinfold. | Baseline, 30, 60 and 90 days after intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal circumference | Abdominal circumference changes measured by perimetry method. | Baseline, 30, 60 and 90 days after intervention. |
| Inflammatory profile | Inflammatory profile analyzed through level of interleukin - 6, tumor necrosis factor - alfa, monocyte chemotactic protein-1 and leptin. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodrigo DM Plentz, PhD | Contact | 55 51 91131651 | roplentz@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Rodrigo DM Plentz, PhD | Federal University of Health Science of Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Health Science of Porto Alegre | Porto Alegre | Rio Grande do Sul | 90050170 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31375459 | Derived | Falster M, Schardong J, Santos DPD, Machado BC, Peres A, Rosa PVD, Plentz RDM. Effects of cryolipolysis on lower abdomen fat thickness of healthy women and patient satisfaction: a randomized controlled trial. Braz J Phys Ther. 2020 Sep-Oct;24(5):441-448. doi: 10.1016/j.bjpt.2019.07.005. Epub 2019 Jul 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline, 15 and 30 days after intervention. |
| Body fat mass | Body fat mass changes measured by bioimpedance. | Baseline, 30, 60 and 90 days after intervention. |
| Liver function | Liver function analyzed through aspartate aminotransferase and alanine aminotransferase | Baseline, 15 and 30 days after intervention. |
| Kidney function | Kidney function analyzed through creatinine and urea | Baseline, 15 and 30 days after intervention. |
| Lipids profile | Lipids profile analyzed through high density lipoprotein, low density lipoprotein, cholesterol, triglycerides and glucose levels. | Baseline, 15 and 30 days after intervention |
| Local temperature | Local temperature changes with cryolipolysis measured by thermographic analysis. | 2 minutes before and 2 minutes after intervention and massage |
| Adverse effects | Identification of possible adverse effects by patient report | 15 days after intervention |
| Pain level | Pain level measured by analogue visual pain scale | First minute, twenty-fifth minute, fiftieth minute after intervention and first minute during the massage |
| Body weight and body mass index | Body weight and body mass index | Baseline, 30, 60 and 90 days after intervention. |
| Physical Activity | Level of physical activity measured by the International Physical Activity Questionnaire | Baseline and every 15 days after intervention |