Clinical trial NCT03033004: Cryolipolisis for Abdomen and Flank Fat Reduction
Official title: Cryolipolisis for Subcutaneous Abodomen and Flank Fat Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subcutaneous Fat Disorder
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Sao Carlos
First posted: 2017-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Body mass index \> 29.9 Kg/m2

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fat layer thickness changes measured by ultrasound
timeFrame: 90 days after randomization
Secondary outcomes:
measure: Fat layer thickness changes measured by ultrasound
timeFrame: 30 days after randomization
measure: Fat layer thickness changes measured by ultrasound
timeFrame: 60 days after randomization
measure: Changes in skin viscoelasticity measured by a cutometer
timeFrame: 30 days after randomization
measure: Changes in skin viscoelasticity measured by a cutometer
timeFrame: 60 days after randomization
measure: Changes in skin viscoelasticity measured by a cutometer
timeFrame: 90 days after randomization
measure: Changes in cholesterol levels
timeFrame: 21 days after randomization
measure: Changes in triglyceride levels
timeFrame: 21 days after randomization
measure: Changes in blood levels of alanine aminotransferase (ALT)
timeFrame: 21 days after randomization
measure: Changes in blood levels of aspartate transaminase (AST)
timeFrame: 21 days after randomization
measure: Changes in fasting blood glucose
timeFrame: 21 days after randomization
measure: Changes in circumference measurements
timeFrame: 30 days after randomization
measure: Changes in circumference measurements
timeFrame: 60 days after randomization
measure: Changes in circumference measurements
timeFrame: 90 days after randomization
measure: Changes in body weight
timeFrame: 30 days after randomization
measure: Changes in body weight
timeFrame: 60 days after randomization
measure: Changes in body weight
timeFrame: 90 days after randomization
measure: Subject's satisfaction with regard to treatment measued by a numeric scale ranging from 1 to 3.
timeFrame: 90 days after randomization
measure: Subject's tolerance with regard to treatment measued by a numeric scale ranging from 1 to 3.
timeFrame: 90 days after randomization
Other outcomes:
Locations:
city: Amparo
country: Brazil
facility: Centro de Estudos e Formação Avançada Ibramed.
state: São Paulo
Study officials:
References: