Reduction of Triglycerides in Women on HRT

描述（由申请人提供）：我们正在提议一项为期2年的女性通过活动和营养研究，NIH# HL66468-05。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）是否会导致亚临床动脉粥样硬化的进展减慢，这是通过冠状动脉钙（CAC）、颈动脉内膜中膜厚度（IMT）、斑块和脉搏波速度（PWV）的变化来衡量的。符合试验条件的女性必须腰围（WC）为80厘米，年龄在50-62岁之间，低密度脂蛋白胆固醇（LDLc）为100-160毫克%，体重指数在25-39.9 kg/m2之间。所有人都必须血压正常，但可以接受抗高血压治疗。随机分组干预（生活方式改变[LC]， n=253）和比较（健康教育[HE]， n= 255）于2002年4月开始，2003年10月结束。这项试验的基本原理是基于我们之前的研究结果，这些研究表明，绝经前后体重的增加、WC和胰岛素抵抗的增加、甘油三酯水平的增加、高密度脂蛋白胆固醇（HDLc）的降低以及葡萄糖和胰岛素的增加与绝经后妇女亚临床疾病和心脏病的动脉粥样硬化风险的大幅增加有关。口服雌激素治疗会进一步提高甘油三酯水平、小LDL颗粒、总LDL颗粒和载脂蛋白b，而激素治疗（HT）的这种可能的不利影响可能会削弱拟议的益处。不幸的是，我们的假设被《妇女健康》杂志的结果所证实。在基线时，60%的患者接受HT治疗，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，LC组体重减轻12.6磅，腰围减少8.4厘米，ldl、hdl、甘油三酯、胰岛素和葡萄糖与HE组相比有显著差异。在“走廊步行%英里”这一衡量运动表现的指标上，也有显著差异。在LC组和HE组中，风险因素的变化和体重的变化之间也有很强的联系。这是第一项也是目前唯一一项针对健康绝经后妇女的研究，旨在评估以减肥和降低WC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.