Cryolipolysis on Localized Adiposity

Federal University of Health Science of Porto Alegre28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Subcutaneous Fat

Interventions

CryolipolysisOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Federal University of Health Science of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Subcutaneous fat layer

Subcutaneous fat layer changes measured by ultrasonography and skinfold.

Time frame: Baseline, 30, 60 and 90 days after intervention.

Secondary Outcomes

Abdominal circumference

Abdominal circumference changes measured by perimetry method.

Time frame: 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.

Time frame: Baseline, 15 and 30 days after intervention.

Body fat mass

Body fat mass changes measured by bioimpedance.

Time frame: Baseline, 30, 60 and 90 days after intervention.

Liver function

Liver function analyzed through aspartate aminotransferase and alanine aminotransferase

Time frame: Baseline, 15 and 30 days after intervention.

Kidney function

Kidney function analyzed through creatinine and urea

Time frame: Baseline, 15 and 30 days after intervention.

Lipids profile

Lipids profile analyzed through high density lipoprotein, low density lipoprotein, cholesterol, triglycerides and glucose levels.

Time frame: Baseline, 15 and 30 days after intervention

Local temperature

Central Contacts

Rodrigo DM Plentz, PhD

CONTACT

55 51 91131651 roplentz@yahoo.com.br

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.