Effects of Cryolipolysis on Localized Adiposity: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Subcutaneous fat layer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Cryoglobulinemia
- •Cold urticaria
- •Paroxysmal cold hemoglobinuria
- •Raynaud disease
- •Pregnancy and Breastfeeding
- •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
- •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
结局指标
主要结局
Subcutaneous fat layer
时间窗: Baseline, 30, 60 and 90 days after intervention.
Subcutaneous fat layer changes measured by ultrasonography and skinfold.
次要结局
- Abdominal circumference(Baseline, 30, 60 and 90 days after intervention.)
- Inflammatory profile(Baseline, 15 and 30 days after intervention.)
- Body fat mass(Baseline, 30, 60 and 90 days after intervention.)
- Kidney function(Baseline, 15 and 30 days after intervention.)
- Local temperature(2 minutes before and 2 minutes after intervention and massage)
- Physical Activity(Baseline and every 15 days after intervention)
- Liver function(Baseline, 15 and 30 days after intervention.)
- Lipids profile(Baseline, 15 and 30 days after intervention)
- Adverse effects(15 days after intervention)
- Pain level(First minute, twenty-fifth minute, fiftieth minute after intervention and first minute during the massage)
- Body weight and body mass index(Baseline, 30, 60 and 90 days after intervention.)
研究者
Rodrigo Della Méa Plentz
PhD
Federal University of Health Science of Porto Alegre