Cryolipolysis on Localized Adiposity

Subcutaneous Fat Clinical Trial

Official title:

Effects of Cryolipolysis on Localized Adiposity: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03160976
• Other study ID #: ECLA2017
• Status: Not yet recruiting
• Phase: N/A
• First received: May 16, 2017
• Last updated: May 22, 2017
• Start date: May 25, 2017
• Est. completion date: October 25, 2017

Study information

• Verified date: May 2017
• Source: Federal University of Health Science of Porto Alegre
• Contact: Rodrigo DM Plentz, PhD
• Phone: 55 51 91131651
• Email: roplentz[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: October 25, 2017
• Est. primary completion date: August 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Subcutaneous Fat

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Health Science of Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subcutaneous fat layer	Subcutaneous fat layer changes measured by ultrasonography and skinfold.	Baseline, 30, 60 and 90 days after intervention.
Secondary	Abdominal circumference	Abdominal circumference changes measured by perimetry method.	Baseline, 30, 60 and 90 days after intervention.
Secondary	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.
Secondary	Body fat mass	Body fat mass changes measured by bioimpedance.	Baseline, 30, 60 and 90 days after intervention.
Secondary	Liver function	Liver function analyzed through aspartate aminotransferase and alanine aminotransferase	Baseline, 15 and 30 days after intervention.
Secondary	Kidney function	Kidney function analyzed through creatinine and urea	Baseline, 15 and 30 days after intervention.
Secondary	Lipids profile	Lipids profile analyzed through high density lipoprotein, low density lipoprotein, cholesterol, triglycerides and glucose levels.	Baseline, 15 and 30 days after intervention
Secondary	Local temperature	Local temperature changes with cryolipolysis measured by thermographic analysis.	2 minutes before and 2 minutes after intervention and massage
Secondary	Adverse effects	Identification of possible adverse effects by patient report	15 days after intervention
Secondary	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
Secondary	Body weight and body mass index	Body weight and body mass index	Baseline, 30, 60 and 90 days after intervention.
Secondary	Physical Activity	Level of physical activity measured by the International Physical Activity Questionnaire	Baseline and every 15 days after intervention