Cryolipolysis on Localized Adiposity

Effects of Cryolipolysis on Localized Adiposity: Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Subcutaneous Fat
• Intervention / Treatment: Other: Cryolipolysis

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.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90050170
      • Federal University of Health Science of Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Subjects will only receive the Evaluation Protocol and will be followed for 90 days.
Active Comparator: Intervention Group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Investigators: Principal Investigator: Rodrigo DM Plentz, PhD, Federal University of Health Science of Porto Alegre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 25, 2017
• Primary Completion (Anticipated): August 25, 2017
• Study Completion (Anticipated): October 25, 2017

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: ECLA2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No