Glycemic reduction approaches in polycystic ovary syndrome: a comparative effectiveness study

摘要 多囊卵巢综合征(PCOS)是育龄妇女最常见的内分泌疾病。 患有多囊卵巢综合征的妇女有很高的健康并发症风险。事实上，患有多囊卵巢综合征的女性有3-7次 患2型糖尿病的风险更高，患有多囊卵巢综合征的肥胖女性患2型糖尿病的风险更高。 专家建议，对于患有多囊卵巢综合征的超重和肥胖女性，一线治疗应该是节食 和生活方式干预。然而，专家们对这些干预措施应该给出哪些具体的营养建议意见不一。 鼓励高碳水化合物饮食方法，不同的小组建议不特定的饮食 停止高血压(DASH)饮食，或低碳水化合物饮食。对中国以往饮食试验的系统回顾 PCOS确实发现低碳水化合物饮食在血糖控制、体重减轻、胰岛素和胰岛素方面略有好处 抵抗。这可能是因为碳水化合物的摄入提高了血糖水平，进而增加了胰岛素。 分泌物。然后，胰岛素刺激卵巢雄激素的产生，抑制细胞中脂肪酸的释放。 以前对2型糖尿病的研究表明，不仅是碳水化合物摄入量减少，而且非常低的碳水化合物摄入量- 碳水化合物(VLC)饮食，碳水化合物提供的卡路里不到20%，旨在减轻体重 与其他类型的低碳水化合物饮食相比，血糖水平更高 有效改善多囊卵巢综合征患者的代谢健康。尽管评论指出，VLC饮食已经显示出前景 对于2型糖尿病、糖尿病前期、肥胖和心血管风险，多囊卵巢综合征的证据才刚刚出现。在我们的 最近完成了为期4个月的试验，29名患有多囊卵巢综合征的超重或肥胖女性接受了VLC饮食，我们发现 结果显著改善，包括糖化血红蛋白(HbA1c；-0.21%)和体重 (-7.7%)。我们建议对184名超重或肥胖(体重指数为28-55公斤/平方米)进行为期12个月的随机对照试验。 成人多囊卵巢综合征患者比较VLC饮食和标准护理低脂肪饮食方法的停止 高血压(DASH)饮食。这两个群体的项目都是在线交付的，就像我们的试点研究一样。目标1：实现 比较血糖控制的变化。我们假设VLC版本将带来更大的改进 在12个月大的HbA1c。目的2：比较与2型糖尿病风险相关的次级健康结果的变化， 包括血糖变异性、转换为正常血糖、体重和体脂百分比。我们 假设VLC版本将在12-12岁时导致次级健康结果的更大改善- 月份。目的3：探讨干预的满意度和可接受性。这项建议的指导目标是 探索一种新的饮食和生活方式方法，以降低超重或肥胖的2型糖尿病的未来风险 患有多囊卵巢综合征的肥胖女性。我们预计，拟议的研究将对饮食和 针对这一高危、研究不足的人群的生活方式建议。

ABSTRACT Polycystic ovary syndrome (PCOS) is the most common endocrine disorder for women of reproductive age. Women with PCOS are at a high risk of health complications. In fact, women with PCOS have a 3-7 times higher risk for type 2 diabetes, and obese women with PCOS have an even higher risk of type 2 diabetes. Experts recommend that the first-line treatment for overweight and obese women with PCOS should be diet and lifestyle interventions. Yet, experts disagree about the specific nutritional advice these interventions should encourage, with different groups recommending no particular diet, a high-carbohydrate Dietary Approaches to Stop Hypertension (DASH) diet, or a lower carbohydrate diet. A systematic review of previous dietary trials in PCOS did find a slight benefit of lower carbohydrate diets for glucose control, weight loss, insulin, and insulin resistance. This may be because carbohydrate intake raises glucose levels, which in turn increases insulin secretion. Insulin then stimulates ovarian androgen production and inhibits the release of fatty acids from cells. Previous research in type 2 diabetes suggests that not simply lower carbohydrate intake, but a very low- carbohydrate (VLC) diet, with less than 20% of calories from carbohydrates, designed to reduce body weight and glucose levels more significantly than other types of lower carbohydrate diets, would be even more effective for improving metabolic health in PCOS. Although reviews note that a VLC diet has shown promise for type 2 diabetes, prediabetes, obesity, and cardiovascular risk, evidence for PCOS is only emerging. In our recently completed 4-month trial of 29 overweight or obese women with PCOS following a VLC diet, we found significant improvements in outcomes, including glycated hemoglobin (HbA1c; -0.21%) and body weight (-7.7%). We propose a 12-month randomized, controlled trial for 184 overweight or obese (BMI of 28-55 kg/m2) adults with PCOS comparing a VLC diet and a standard-of-care low-fat, Dietary Approaches to Stop Hypertension (DASH) diet. The program for both groups is delivered online, as in our pilot study. Aim 1: To compare changes in glycemic control. We hypothesize that the VLC version will lead to greater improvements in HbA1c at 12-months. Aim 2: To compare changes in secondary health outcomes tied to type 2 diabetes risk, including glycemic variability, conversion to normoglycemia, body weight, and body fat percentage. We hypothesize that the VLC version will lead to greater improvements in secondary health outcomes at 12- months. Aim 3: To explore intervention satisfaction and acceptability. The guiding objective of this proposal is to explore a novel diet and lifestyle approach for reducing the future risk of type 2 diabetes for overweight or obese women with PCOS. We anticipate that the proposed research will have an important impact on diet and lifestyle recommendations for this high-risk, understudied population.