Cryolipolysis on Localized Adiposity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Cryolipolysis on Localized Adiposity: Randomized Clinical Trial

Conditions
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Subcutaneous Fat

Intervention / Treatment
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* Other: Cryolipolysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Subjects will only receive the Evaluation Protocol and will be followed for 90 days. | |
| Active Comparator: Intervention Group<br>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). | Other: Cryolipolysis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subcutaneous fat layer | Subcutaneous fat layer changes measured by ultrasonography and skinfold. | Baseline, 30, 60 and 90 days after intervention. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |