NCT00993213已完成不适用
Mechanisms Defending Fat Mass in Humans After Lipectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Changes in body composition.
研究概览
简要总结
Liposuction surgery is common, yet animal and limited human data suggest that fat returns when removed. This study was designed as a 1-year randomized-controlled trial of suction lipectomy versus no intervention to determine if adipose tissue is defended, and if so to determine the anatomic pattern of redistribution.
详细描述
Specific Aims:
- To determine if suction lipectomy fails to modify regional and/or total body fat over three years.
- To determine if the expression of candidate genes predicts and/or relates to subcutaneous adipose tissue growth or depletion in subcutaneous adipose tissue after suction lipectomy.
- To examine adipose tissue before and after suction lipectomy to uncover novel genes where expression predicts and/or relates to subcutaneous adipose tissue growth or depletion after subcutaneous suction lipectomy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Eligible premenopausal women between the ages of 18-50 years;
- •BMI of 22-27 kg/m2 at the subjects maximum body weight;
- •Weight stable for at least 3 months (defined as a <5-7% change from the maximum weight over 3-6 months);
- •Non-smokers.
排除标准
- •Any history of glucose intolerance, dyslipidemia, liver, kidney and cardiac disease, hypertension, cancer or any other chronic debilitating disorder that might have interfered with a 'normal' lifestyle, e.g. nutrition, physical activity;
- •Thyroid hormone replacement with abnormal thyroid stimulating hormone (TSH) results;
- •Use of oral contraceptives if the subject did/could not remain on therapy throughout study participation.
- •Reduced-obese, defined as a history of:
- •obesity and weight loss >10% of maximum body weight, or
- •liposuction or gastric bypass surgery;
- •Evidence of body dysmorphic disorder;
- •Taking sex steroids, glucocorticoids, or medications affecting carbohydrate and lipid metabolism;
- •Hematocrit, hemoglobin, white blood cell count (WBC), platelet count, liver or renal function tests out of the normal range;
- •Fasting plasma glucose >110 mg/dL;
- •Triglycerides >200 mg/dL;
- •High density lipoprotein (HDL) cholesterol <35 mg/dL;
- •Low density lipoprotein (LDL) cholesterol >160 mg/dL;
- •Proteinuria;
- •Blood pressure >140/90 mm/Hg;
- •Electrocardiogram abnormalities;
- •History of claustrophobia;
- •Placement of metal implants*
- •History of internal metal fragments*
- •*Were evaluated by the radiologist prior to study determination*
结局指标
主要结局
Changes in body composition.
时间窗: Baseline, 6wks, 6mos, 1-year
Changes in body composition as measured by Dual X-ray Absorptiometry (DXA).
次要结局
未报告次要终点
研究者
研究点 (2)
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