Effect of Cryolipolysis on Inflammatory Factors in Obese Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Serum interleukin-6
研究概览
简要总结
This study was conducted to investigate the effect of Cryolipolysis on inflammatory factors in obese postmenopausal women.
详细描述
The onset of menopause is associated with a low systemic inflammatory status, an inflammation manifested by increased serum levels of the key proinflammatory cytokines, interleukin (IL)-1, IL-6 or tumor necrosis factor α (TNF-α).
Little information is available on menopause-related differences in inflammatory markers. Few studies have compared CRP levels and leptin in women as a function of menopausal status, finding no differences between premenopausal and postmenopausal women. The relationship between hormonal declines associated with menopause and increased serum levels of proinflammatory cytokines is not yet fully understood.
Cryolipolysis selectively destructs the fat cells, by decreasing the subcutaneous fat temperature through controlled cooling without causing any damage to the surrounding tissues Cryolipolysis induces an inflammation and fat cell fibrosis, which causes the death of adipocytes (apoptosis). Macrophages subsequently engulf and digest the dyed adipocytes and, thereby, gradually decreases the fat layer thickness, which may affect the inflammatory body reaction and factors. However, the systemic effect of Cryolipolysis alone was not approved.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All participants were postmenopausal women.
- •Their ages were ranged from 50 to 60 years old.
- •Body mass index was ranged from 30-40 kg/m
- •Waist to hip Ratio was between 0.8-1.0.
排除标准
- •Systematic disease (uncontrolled hypertension, diabetes mellitus).
- •Thyroid, liver and kidney dysfunctions.
- •Psychiatric disorders.
- •Women received any hormonal therapy or received corticosteroids in the last six months prior to the study.
结局指标
主要结局
Serum interleukin-6
时间窗: 12 weeks
Serum interleukin-6 (IL-6) levels were measured from venous blood samples using an enzyme-linked immunosorbent assay (ELISA). IL-6 concentrations were expressed in picograms per milliliter (pg/mL). The normal serum IL-6 level in healthy adults is generally less than 7 pg/mL, higher level indicates inflammatory conditions.
C- Reactive Proteins
时间窗: 12 weeks
Serum C-reactive protein (CRP) levels were measured from venous blood samples using an immunoturbidimetric assay. CRP concentrations were expressed in milligrams per liter (mg/L). A CRP value below 5 mg/L is generally considered within the normal range. Higher levels indicate inflammatory diseases.
次要结局
- Body weight(12 weeks)
- Body mass index(12 weeks)
- waist circumference(12 weeks)
- Hip circumference(12 weeks)
- waist-hip ratio(12 weeks)
- Muscle mass(12 weeks)
- Body fat weight(12 weeks)
- Body fat percentage(12 weeks)
- Visceral fat(12 weeks)
研究者
Nada Elsayed Mohamed
Principal investigator
Cairo University