Subcutaneous Fat
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERCryolipolysis
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.
Sponsors
Federal University of Health Science of Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * Age 18 to 45 or not being on menopause * Sedentary according to International Physical Activity Questionnaire * Body Mass Index lower than 27 Kg/m² * Skinfold: more than 3 centimeters at the lower abdomen
Exclusion criteria
* Cryoglobulinemia * Cold urticaria * Paroxysmal cold hemoglobinuria * Raynaud disease * Pregnancy and Breastfeeding * Cancer * Vascular diseases * Heart diseases * Epidermal lesions at the site of application * Autoimmune diseases * Osteoporosis * Metallic implants and pacemaker * Alterations of sensibility * Inflammatory process and active infection * Abdominal hernia * Abdominal muscle diastasis * Diabetes * Anemia * Previous plastic surgery on the area * Liver and kidney diseases * Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subcutaneous fat layer | Baseline, 30, 60 and 90 days after intervention. | Subcutaneous fat layer changes measured by ultrasonography and skinfold. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory profile | Baseline, 15 and 30 days after intervention. | Inflammatory profile analyzed through level of interleukin - 6, tumor necrosis factor - alfa, monocyte chemotactic protein-1 and leptin. |
| Body fat mass | Baseline, 30, 60 and 90 days after intervention. | Body fat mass changes measured by bioimpedance. |
| Liver function | Baseline, 15 and 30 days after intervention. | Liver function analyzed through aspartate aminotransferase and alanine aminotransferase |
| Kidney function | Baseline, 15 and 30 days after intervention. | Kidney function analyzed through creatinine and urea |
| Lipids profile | Baseline, 15 and 30 days after intervention | Lipids profile analyzed through high density lipoprotein, low density lipoprotein, cholesterol, triglycerides and glucose levels. |
| Abdominal circumference | Baseline, 30, 60 and 90 days after intervention. | Abdominal circumference changes measured by perimetry method. |
| Adverse effects | 15 days after intervention | Identification of possible adverse effects by patient report |
| Pain level | First minute, twenty-fifth minute, fiftieth minute after intervention and first minute during the massage | Pain level measured by analogue visual pain scale |
| Body weight and body mass index | Baseline, 30, 60 and 90 days after intervention. | Body weight and body mass index |
| Physical Activity | Baseline and every 15 days after intervention | Level of physical activity measured by the International Physical Activity Questionnaire |
| Local temperature | 2 minutes before and 2 minutes after intervention and massage | Local temperature changes with cryolipolysis measured by thermographic analysis. |
Countries
Brazil
Contacts
Primary ContactRodrigo DM Plentz, PhD
Outcome results
None listed