Reduction of Triglycerides in Women on HRT

描述(由申请人提供)：我们建议对NIH#HL66468-05《运动中的妇女通过活动和营养研究》进行为期2年的持续研究。这项试验的主要目标是确定包括减肥、运动、低饱和脂肪和胆固醇饮食以及适度增加多不饱和化合物在内的非药物干预是否会减缓亚临床动脉粥样硬化的进展，这是通过冠状动脉钙化(CAC)、颈动脉内膜中层厚度(IMT)以及斑块和脉搏波速度(PWV)的变化来衡量的。有资格参加试验的女性必须腰围80厘米，年龄50-62岁，低密度脂蛋白胆固醇(LDLc)100-160毫克%，体重指数25-39.9公斤/平方米。所有患者都必须血压正常，但可以接受降压治疗。随机分为干预(改变生活方式[LC]，n=253)和对照(健康教育[HE]，n=255)，于2002年4月开始，2003年10月完成。我们之前的研究结果表明，从围绝经期到绝经后体重增加，腰围和胰岛素抵抗增加，甘油三酯水平增加，高密度脂蛋白胆固醇(HDLc)降低，血糖和胰岛素增加与动脉粥样硬化的风险大幅增加(以绝经后妇女的亚临床疾病和心脏病来衡量)有关，口服雌激素治疗将进一步提高甘油三酯水平、小颗粒低密度脂蛋白、总低密度脂蛋白和载脂蛋白-B，并且激素治疗(HT)这种可能的不良反应可能会削弱拟议的益处，因此提出该试验的理由。不幸的是，我们的假设得到了《妇女健康》的结果的证实。在基线时，60%的患者接受高压氧治疗，30个月后，24%的患者接受高压氧治疗。在30个月时，近90%的人仍在参与。30个月时，体重为12.6磅。LC组体重减轻，腰围减少8.4 cm，低密度脂蛋白(LDLc)、高密度脂蛋白胆固醇(HDLc)、甘油三酯、胰岛素、血糖在LC组与HE组比较有显著差异。走廊步行百分比也有显著差异，这是一种运动表现的衡量标准。在LC组和HE组中，风险因素变化和体重变化之间也有很强的相关性。这是第一项也是目前唯一一项在健康的绝经后妇女中评估以减肥和减少WC为重点的积极生活方式干预是否可以阻止亚临床动脉硬化进展的研究之一。

DESCRIPTION (provided by applicant): We are proposing a 2 year continuation of the Women On the Move through Activity And Nutrition Study, NIH# HL66468-05. The primary goal of this trial is to determine whether a nonpharmacological intervention that includes weight loss, exercise and low saturated fat and cholesterol diet and moderate increase in polyunsaturates will result in the slowing of progression of subclinical atherosclerosis as measured by changes in coronary artery calcium (CAC), carotid intima media thickness (IMT) and plaque and pulse wave velocity (PWV). To be eligible for the trial the women had to have a waist circumference (WC) of 80 cm, age 50-62 and low density lipoprotein cholesterol (LDLc) of 100-160 mg% and body mass index between 25-39.9 kg/m2. All had to be normotensive but could be on antihypertensive therapy. Randomization into intervention (Lifestyle Change [LC], n=253) and comparison (Health Education [HE], n= 255) began in 4/2002 and was completed in 10/2003. The rationale for the trial based on the results of our previous studies showing that increase in weight from the peri- to post-menopause, increase in WC and insulin resistance, increased triglyceride levels, reductions in high density lipoprotein cholesterol (HDLc) and increase in glucose and insulin was associated with a substantial increase risk of atherosclerosis as measured by subclinical disease and heart disease in postmenopausal women, that oral estrogen therapy would further raise triglyceride levels, small LDL particles, total LDL particles and apolipoprotein-B and that this possible adverse effect of hormone therapy (HT) could perhaps blunt the proposed benefits. Our hypothesis was borne out, unfortunately, by the results of the Women's Health. At baseline, 60% were on HT and at 30 months, 24%. At 30 months, close to 90% were still participating. At 30 months, there was a 12.6 Ib. weight loss in the LC group, 8.4 cm decrease in WC and significant differences in the LC versus HE group in LDLc, HDLc, triglycerides, insulin and glucose. There was also a significant difference in the %-mile corridor walk, a measure of exercise performance. In both the LC and HE groups there was also a very strong association between risk factor changes and changes in weight. This is one of the first and currently the only study in healthy postmenopausal women to evaluate whether aggressive lifestyle interventions focusing on weight loss and decrease in WC can stop the progression of subclinical atherosclerosis.