Clinical trial NCT03160976: Cryolipolysis on Localized Adiposity
Official title: Effects of Cryolipolysis on Localized Adiposity: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subcutaneous Fat
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subcutaneous fat layer
timeFrame: Baseline, 30, 60 and 90 days after intervention.
Secondary outcomes:
measure: Abdominal circumference
timeFrame: Baseline, 30, 60 and 90 days after intervention.
measure: Inflammatory profile
timeFrame: Baseline, 15 and 30 days after intervention.
measure: Body fat mass
timeFrame: Baseline, 30, 60 and 90 days after intervention.
measure: Liver function
timeFrame: Baseline, 15 and 30 days after intervention.
measure: Kidney function
timeFrame: Baseline, 15 and 30 days after intervention.
measure: Lipids profile
timeFrame: Baseline, 15 and 30 days after intervention
measure: Local temperature
timeFrame: 2 minutes before and 2 minutes after intervention and massage
measure: Adverse effects
timeFrame: 15 days after intervention
measure: Pain level
timeFrame: First minute, twenty-fifth minute, fiftieth minute after intervention and first minute during the massage
measure: Body weight and body mass index
timeFrame: Baseline, 30, 60 and 90 days after intervention.
measure: Physical Activity
timeFrame: Baseline and every 15 days after intervention
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Science of Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Rodrigo DM Plentz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.