Effect of Weight Loss and Lifestyle Changes on Vascular Inflammatory Markers in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin)
研究概览
简要总结
Obesity is an independent risk factor for cardiovascular disease, which may be mediated by increased secretion of proinflammatory cytokines by adipose tissue.
To determine the effect of a program of changes in lifestyle designed to obtain a sustained reduction of body weight on markers of systemic vascular inflammation and insulin resistance.
Randomized single-blind trial conducted from February 1999 to February 2002 at a university hospital in Italy.
One hundred twenty premenopausal obese women (body mass index 30) aged 20 to 46 years without diabetes, hypertension, or hyperlipidemia.
The 60 women randomly assigned to the intervention group received detailed advice about how to achieve a reduction of weight of 10% or more through a low-energy Mediterranean-style diet and increased physical activity. The control group (n = 60) was given general information about healthy food choices and exercise.
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
- 20 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •obese premenopausal women,
- •aged 20 to 46 years
- •sedentary (<1 h/wk of physical activity)
- •with no evidence of participation in diet reduction programs within the last 6 months.
排除标准
- •type 2 diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dL [7.8-11.1 mmol/L] 2 hours after a 75-g oral glucose load)
- •hypertension (blood pressure >140/90 mm Hg)
- •cardiovascular disease, psychiatric problems
- •history of alcohol abuse (intake of 500 g/wk in the last year)
- •current smoking
- •any medication use.
结局指标
主要结局
Vascular inflammatory markers (IL-6, IL-18, CRP, Adiponectin)
时间窗: 24 months
次要结局
- Insulin resistance (HOMA)(24 months)