REDUCTION OF TRIGLYCERIDES IN WOMEN ON HRT

描述（由申请人提供）：激素的风险和益处 替代疗法（HRT）近年来受到越来越多的关注 由于HERS和WHI试验的结果， 癌症，新疗法，即，SERMs和降脂药物，二磷酸盐， 更好地了解激素代谢和疾病。我们已经展示了在 一些研究表明HRT的潜在益处受到生活方式的限制， 辅因子，特别是体重增加，肥胖和内脏腹部增加 脂肪相关的脂蛋白代谢变化，炎症标志物， 雌激素代谢物我们建议对500名女性进行HRT的随机试验 至少两年，52-60岁，三年或更长时间 绝经后，以测试是否减少腰围，甘油三酯， 高密度LDL c、LDL颗粒数、CPR、积极饮食运动的PAI-1， 与健康教育对照相比， 亚临床血管疾病测量的回归。述干预 旨在减少总脂肪摄入量的17%的热量，1300公斤， 热量，并增加适度的活动，每周150-240分钟，以获得 重量减少了10%主要终点将是20%或 甘油三酯水平至少降低20 mg，腰围减少5 cm 周长，LDLc降低10%。这将导致变化 在亚临床测量中，包括颈动脉超声、电子束 冠状动脉和主动脉计算机断层扫描，脉搏波速度，内皮 桡动脉的功能和张力测定。脂蛋白的NMR光谱， 炎症标记物和雌激素代谢物也将被评估。 因此，本试验的主要目标是修改 HRT使用者的亚临床疾病。

DESCRIPTION (provided by applicant): The risk and benefits of hormone replacement therapy (HRT) have come under increased concern in recent years because of the results of the HERS and WHI trials, the increased risk of breast cancer, new therapies, i.e., SERMs and lipid lowering drugs, bisphosphorates, and better understanding of hormone metabolism and disease. We have shown in several studies that the potential benefits of HRT are limited by lifestyle, cofactors, specifically weight gain, obesity and increased visceral abdominal fat associated metabolic changes in lipoproteins, inflammatory markers and estrogen metabolites. We are proposing a randomized trial of 500 women, on HRT for at least two years, aged 52-60 years, and three or more years postmenopausal to test whether reduction in waist circumference, triglycerides, dense LDLc, number of LDL particles, CPR, PAI-I by aggressive diet exercise, versus a health education control will decrease progression or result in regression of measures of subclinical vascular disease. The intervention is designed to reduce total fat intake to 17 percent of calories, 1300 kilo calories, and increase moderate activity to 150-240 minutes per week to obtain a 10 percent reduction in weight. The primary endpoint will be a 20 percent or at least a 20 mg decrease in triglyceride levels, a 5 cm decrease in waist circumference, and a 10 percent decrease in LDLc. This will result in changes in subclinical measurements including carotid ultrasound, electron beam computer tomography of the coronary and aorta, pulse wave velocity, endothelial function, and tonometry of the radial artery. NMR spectroscopy of lipoproteins, inflammatory markers, and estrogen metabolites will also be evaluated. Therefore, the primary goal of this trial is the modification of measures of subclinical disease among HRT users.