Reduction of Triglycerides in Women on HRT

描述（由申请人提供）：我们建议继续进行为期2年的活动和营养研究，NIH#HL 66468 -05。本试验的主要目的是确定非药物干预（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脂肪酸）是否会减缓亚临床动脉粥样硬化的进展，通过冠状动脉钙（CAC）、颈动脉内膜中层厚度（IMT）、斑块和脉搏波速度（PWV）的变化进行测量。为了有资格参加试验，女性必须具有80 cm的腰围（WC）、50-62岁和100-160 mg%的低密度脂蛋白胆固醇（LDLc）和25-39.9 kg/m2的体重指数。所有患者血压正常，但可能正在接受抗高血压治疗。随机分为干预组（生活方式改变[LC]，n=253）和对照组（健康教育[HE]，n= 255），于2002年4月开始，于2003年10月完成。根据我们先前的研究结果，本试验的基本原理表明，绝经后女性从绝经前到绝经后体重增加、WC和胰岛素抵抗增加、甘油三酯水平升高、高密度脂蛋白胆固醇（HDL c）降低以及葡萄糖和胰岛素升高与动脉粥样硬化风险大幅增加相关，如通过亚临床疾病和心脏病测量的，口服雌激素治疗会进一步升高甘油三酯水平、小LDL颗粒、总LDL颗粒和载脂蛋白-B，激素治疗（HT）的这种可能的副作用可能会削弱所提出的益处。不幸的是，我们的假设被妇女健康调查的结果所证实。在基线时，60%的患者接受HT治疗，在30个月时，24%的患者接受HT治疗。在30个月时，接近90%的人仍在参与。30个月时，有12.6磅。LC组体重减轻，WC减少8.4 cm，LC组与HE组相比，LDLc、HDLc、甘油三酯、胰岛素和葡萄糖存在显著差异。在%-英里走廊步行中也有显著差异，这是一种运动表现的衡量标准。在LC和HE组中，危险因素变化与体重变化之间也存在非常强的相关性。这是第一个也是目前唯一一个在健康绝经后妇女中进行的研究，旨在评估以体重减轻和WC减少为重点的积极生活方式干预是否可以阻止亚临床动脉粥样硬化的进展。

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.