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: 10540706
• 负责人: Laura Saslow
• 金额: $ 61.33万
• 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/10540706
• 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 Stimulations; Overweight; Participant; Pilot Projects; Polycystic Ovary Syndrome; Population; Prediabetes syndrome; Production; Publishing; Quality of life; 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; randomized, clinical trials; 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.

抽象的 多囊卵巢综合征（PCOS）是生殖年龄女性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。实际上，患有PCOS的女性有3-7次 2型糖尿病的风险更高，患有PCOS的肥胖女性患有2型糖尿病的风险更高。 专家建议对PCOS的超重和肥胖女性的一线治疗应为饮食 和生活方式干预。但是，专家不同意这些干预措施的特定营养建议 鼓励不同的小组建议不具体饮食，一种高碳水化合物的饮食方法 停止高血压（破折号）饮食或较低的碳水化合物饮食。对先前饮食试验的系统评价 PCOS确实发现较低的碳水化合物饮食可用于控制葡萄糖，减肥，胰岛素和胰岛素 反抗。这可能是因为碳水化合物摄入量会提高葡萄糖水平，从而增加胰岛素 分泌。然后，胰岛素刺激卵巢雄激素的产生，并抑制细胞中脂肪酸的释放。 先前在2型糖尿病的研究表明，不仅降低碳水化合物的摄入量，而且还很低。 碳水化合物（VLC）饮食，碳水化合物的卡路里不到20％，旨在减轻体重 与其他类型的低碳水化合物饮食相比，葡萄糖水平更明显 有效改善PCOS代谢健康。尽管评论指出，VLC饮食已经显示出承诺 对于2型糖尿病，糖尿病前，肥胖和心血管风险，PCOS的证据仅出现。在我们的 最近完成了4个月的29名超重或肥胖女性，以VLC饮食后，我们发现 结局的显着改善，包括糖化血红蛋白（HBA1C； -0.21％）和体重 （-7.7％）。我们提出了一个为184个超重或肥胖的12个月随机对照试验（BMI为28-55 kg/m2） 与PCO的成年人比较VLC饮食和现成标准的低脂方法的饮食方法 高血压（破折号）饮食。与我们的试点研究一样，这两个小组的计划均在线交付。目标1：到 比较血糖控制的变化。我们假设VLC版本将导致更大的改进 在12个月的HBA1C中。目标2：比较与2型糖尿病风险相关的中等健康结果的变化， 包括血糖变异性，转化为正常血糖，体重和体内脂肪百分比。我们 假设VLC版本将导致12-- 月份。目标3：探索干预满意度和可接受性。该提议的指导目标是 探索一种新颖的饮食和生活方式方法，以减少2型糖尿病的未来风险，以超重或 肥胖女性患有PCOS。我们预计拟议的研究将对饮食和 对于这个高风险，研究的人口的生活方式建议。