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

多囊卵巢综合征的降血糖方法：比较有效性研究

• 批准号: 10363371
• 负责人: Laura Saslow
• 金额: $ 63.98万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-15 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10363371
• 关键词: Acne; Adherence; Adult; Age; Androgens; Beta Cell; Blood Tests; Body Weight; Body Weight decreased; Body fat; Body mass index; Calories; Carbohydrates; Cells; Clinical; Control Groups; DASH diet; Development; Diet; Dietary Carbohydrates; Dietary Intervention; Dimensions; Dropout; Dysmenorrhea; Early Diagnosis; Endocrine System Diseases; Face; Fatty Acids; Fatty acid glycerol esters; Formulation; Functional disorder; Future; Glucose; Glycosylated Hemoglobin; Glycosylated hemoglobin A; Hair; Health; Hirsutism; Hormones; Hyperandrogenism; Hyperinsulinism; Individual; Infertility; Insulin; Insulin Resistance; Intake; Intervention; Irregular Menstruation; Life Style; Lipids; Measurement; Measures; Menstrual cycle; Menstruation; Metabolic; Non-Insulin-Dependent Diabetes Mellitus; Nutritional; Obesity; Outcome; Ovarian; Overweight; Participant; Pilot Projects; Polycystic Ovary Syndrome; Population; Prediabetes syndrome; Production; Publishing; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Research; Risk; Sex Hormone-Binding Globulin; Symptoms; Target Populations; Testing; Testosterone; Text Messaging; Time; Woman; blood glucose regulation; cardiovascular disorder risk; cardiovascular risk factor; chronic anovulation; comparative effectiveness study; cost; design; diabetes risk; dietary; dietary adherence; dietary restriction; evidence base; evidence based guidelines; experience; glycemic control; high risk; improved; insulin secretion; lifestyle intervention; novel; nutrition; obesity risk; online delivery; pilot trial; primary outcome; programs; randomized trial; reproductive; satisfaction; side effect; standard of care; systematic review

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.

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PCOS的女性患健康并发症的风险很高。事实上，患有PCOS的女性有3-7次 患2型糖尿病的风险更高，患有PCOS的肥胖女性患2型糖尿病的风险更高。 专家建议，超重和肥胖PCOS女性的一线治疗应该是饮食 和生活方式干预。然而，专家们不同意这些干预措施应该提供的具体营养建议。 鼓励，与不同的团体建议没有特定的饮食，高碳水化合物的饮食方法， 停止高血压（DASH）饮食，或低碳水化合物饮食。对既往饮食试验的系统回顾， 多囊卵巢综合征确实发现低碳水化合物饮食对血糖控制、体重减轻、胰岛素和胰岛素有轻微的益处 阻力这可能是因为碳水化合物的摄入提高了葡萄糖水平，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并抑制脂肪酸从细胞中释放。 以前对2型糖尿病的研究表明，不仅仅是减少碳水化合物的摄入，而是非常低的- 碳水化合物（VLC）饮食，碳水化合物的热量不到20%，旨在减轻体重 和葡萄糖水平比其他类型的低碳水化合物饮食更显着， 有效改善PCOS患者的代谢健康。虽然评论指出，VLC饮食已显示出希望， 对于2型糖尿病、糖尿病前期、肥胖和心血管风险，PCOS的证据才刚刚出现。在我们 我们最近完成了一项对29名超重或肥胖的PCOS妇女在VLC饮食后进行的为期4个月的试验， 结果显着改善，包括糖化血红蛋白（HbA 1c; -0.21%）和体重 (-7.7%).我们提出了一项为期12个月的随机对照试验，184超重或肥胖（BMI为28-55 kg/m2） 成年PCOS患者比较VLC饮食和标准护理低脂肪，饮食方法停止 高血压（DASH）饮食。这两组的课程都是在线提供的，就像我们的试点研究一样。目标1： 比较血糖控制的变化。我们假设VLC版本将带来更大的改进 12个月时的HbA 1c。目的2：比较与2型糖尿病风险相关的次要健康结局的变化， 包括血糖变异性、向正常血糖的转化、体重和体脂百分比。我们 假设VLC版本将导致12岁时次要健康结局的更大改善- 个月目的3：探讨干预的满意度和可接受性。本建议的指导目标是 探索一种新的饮食和生活方式方法，以降低超重或肥胖者未来患2型糖尿病的风险。 患有PCOS的肥胖女性我们预计，拟议的研究将对饮食产生重要影响， 生活方式的建议，这一高风险，研究不足的人群。