Cryolipolysis on Localized Adiposity

Not Applicable

• Conditions: Subcutaneous Fat

• Registration Number: NCT03160976
• Lead Sponsor: Federal University of Health Science of Porto Alegre

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.

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-19
• Last Update Submitted: 2017-05-22
• Last Update Posted: 2017-05-24
• Study Start: 2017-05-25
• Primary Completion: 2017-08-25
• Study Completion: 2017-10-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subcutaneous fat layer	Baseline, 30, 60 and 90 days after intervention.	Subcutaneous fat layer changes measured by ultrasonography and skinfold.

Secondary Outcome Measures

Name	Time	Method
Abdominal circumference	Baseline, 30, 60 and 90 days after intervention.	Abdominal circumference changes measured by perimetry method.
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.
Kidney function	Baseline, 15 and 30 days after intervention.	Kidney function analyzed through creatinine and urea
Local temperature	2 minutes before and 2 minutes after intervention and massage	Local temperature changes with cryolipolysis measured by thermographic analysis.
Physical Activity	Baseline and every 15 days after intervention	Level of physical activity measured by the International Physical Activity Questionnaire
Liver function	Baseline, 15 and 30 days after intervention.	Liver function analyzed through aspartate aminotransferase and alanine aminotransferase
Lipids profile	Baseline, 15 and 30 days after intervention	Lipids profile analyzed through high density lipoprotein, low density lipoprotein, cholesterol, triglycerides and glucose levels.
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

Trial Locations

Locations (1)

Federal University of Health Science of Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil