Cryolipolisis for Abdomen and Flank Fat Reduction
- Conditions
- Subcutaneous Fat Disorder
- Registration Number
- NCT03033004
- Lead Sponsor
- Universidade Cidade de Sao Paulo
- Brief Summary
Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion Cryolipolysis. The region will be treated according to the individual need, in the region of abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60 and 90 days after randomization. Blood collections will also be performed at baseline and between 14 and 21 days after randomization for evaluation of lipid profile and liver function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Healthy subjects
- Body mass index > 29.9 Kg/m2
- Pregnancy
- Diabetes
- Cancer
- Vascular diseases
- Heart diseases
- Liposuction or other surgical procedures for body contouring
- Active infection
- Wounds
- Paroxysmal cold hemoglobinuria
- Cold urticaria
- Significant weight changes in the past 3 months or during treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Fat layer thickness changes measured by ultrasound 90 days after randomization
- Secondary Outcome Measures
Name Time Method Changes in fasting blood glucose 21 days after randomization Changes in body weight 90 days after randomization Changes in skin viscoelasticity measured by a cutometer 90 days after randomization Changes in circumference measurements 90 days after randomization Fat layer thickness changes measured by ultrasound 60 days after randomization Changes in cholesterol levels 21 days after randomization Cholesterol levels will be measured in mg/dL
Changes in triglyceride levels 21 days after randomization Triglyceride levels will be measured in mg/dL
Changes in blood levels of alanine aminotransferase (ALT) 21 days after randomization Changes in blood levels of aspartate transaminase (AST) 21 days after randomization Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3. 90 days after randomization 1= unsatisfied; 2= indifferent; 3= satisfied
Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3. 90 days after randomization 1 = intolerable; 2= tolerable; 3= comfortable
Trial Locations
- Locations (1)
Centro de Estudos e Formação Avançada Ibramed.
🇧🇷Amparo, São Paulo, Brazil
Centro de Estudos e Formação Avançada Ibramed.🇧🇷Amparo, São Paulo, Brazil