Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans

Summary

Participation Requirements

Description

This is a longitudinal, non-randomized clinical trial to assess the biology of AT after the use of cryolipolysis. The study will be developed at "Clinica Dra Ligia Colucci" in partnership with the Federal University of Minas Gerais (UFMG). The project will be submitted for evaluation by the Research...

This is a longitudinal, non-randomized clinical trial to assess the biology of AT after the use of cryolipolysis. The study will be developed at "Clinica Dra Ligia Colucci" in partnership with the Federal University of Minas Gerais (UFMG). The project will be submitted for evaluation by the Research Ethics Committee (COEP / UFMG). All participants must sign the informed consent form (ICF), before the study begins. The experimental design will consist of five stages. Initially, women will be public recruitment. Through telephone contact, the inclusion and exclusion criteria will be verified, and volunteers who meet the criteria will be invited to attend the clinic for the first stage of the study. The presentation of the research, will be carried out 7 days before the beginning of the treatment, will consist of presenting the project to the volunteers, explaining all the risks and benefits related to the study and request the signature of the ICF. After 7 days, the volunteers must return to the clinic, then start the study. In the initial evaluation, an anamnesis of the volunteers will be carried out with a standardized form, including socioeconomic and clinical data, data on the use of medications, alcohol consumption, physical activity and food consumption. In addition, anthropometric assessments will be performed where weight, height, waist, abdominal and hip circumference will be measured. Ultrasonography will also be performed; the abdominal region will be photographed and blood will be collected to measure lipolytic and inflammatory markers and a biopsy of the subcutaneous WAT in the lower abdomen via umbilical scar. In addition, questionnaires will be applied to check the volunteers' satisfaction with the treatment. After 30 days, the volunteers must return to the clinic for time 0 (T0), where anthropometric assessments will be repeated as control variables. Ultrasound and blood collection will also be performed. Then the volunteers will be submitted to cryolipolysis in the abdominal region by the Coolsculpting® system. After 3 days of performing the Coolsculpting® procedure, the volunteers must return to the clinic for time 3 (T3), to perform a new biopsy of the subcutaneous WAT in the lower abdomen via the umbilical scar. After 60 days of the cryolipolysis, the volunteers must return to the clinic for the time 60 (T60), where all the evaluations of the initial evaluation will be carried out again and a personal satisfaction questionnaire will be applied in relation to the result of the procedure. Therefore, the study will total 97 days of monitoring of women, who will be instructed to maintain healthy lifestyle habits, according to the conventional lifestyle of each one of them. The data, images and biological materials (blood and adipose tissue biopsy) collected in the research will be filed with the researcher responsible for a period of 5 (five) years at the Experimental Nutrition Laboratory, room 315, of the UFMG School of Nursing and after that time will be destroyed. In case of occurrence of paradoxical adipose hyperplasia after the procedure, a case study of the possible affected patients will be carried out.

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