Perinatal outcomes with carbohydrate restriction for gestational diabetes

妊娠期糖尿病限制碳水化合物的围产期结局

• 批准号: 7516423
• 负责人: Kimberly Kovach Trout
• 金额: $ 15万
• 依托单位: VILLANOVA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7516423
• 关键词: Affect; African American; American; Asians; Birth Weight; Blood Glucose; Blood Glucose Self-Monitoring; Caloric Restriction; Calories; Carbohydrates; Caring; Cesarean section; Cessation of life; Clinical; Communities; Control Groups; Daily; Diabetes Mellitus; Diagnosis; Diet; Disease; Dystocia; Event; Fasting; Female of child bearing age; Gestational Diabetes; Glucose; Glucose tolerance test; Goals; Guidelines; Health; Hispanics; Hour; Incidence; Infant; Insulin; Intake; Intention; Macronutrients Nutrition; Medical; Memory; Monitor; Morbidity - disease rate; Mothers; Neonatal; Nerve; Non-Insulin-Dependent Diabetes Mellitus; Normal Range; Obesity; Outcome; Outcome Measure; Paralysed; Patients; Perinatal; Pharmaceutical Preparations; Population; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Pregnant Women; Prevalence; Procedures; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Rate; Recommendation; Risk; Sampling; Screening procedure; Shoulder; Students; Test Result; Testing; Time; United States; Weight Gain; Woman; base; blood glucose regulation; carbohydrate metabolism; clinical research site; design; dietary restriction; ethnic minority population; health disparity; impaired glucose tolerance; improved; infant outcome; medically necessary care; meter; sound; stillbirth

DESCRIPTION (provided by applicant): Gestational diabetes mellitus (GDM) is one of the most common pregnancy complications. In order to reduce complications, one of the goals of treatment is to maintain maternal blood glucose levels within as close to normal range as possible. For some women with GDM, insulin is required to achieve optimal blood glucose levels; however, most women with GDM do not receive medication and are "diet-controlled". Despite this, there is little evidence about the optimal composition of macronutrients in the diet for women with GDM. The proposed randomized controlled trial is designed to test the hypothesis that a lower carbohydrate diet will help pregnant women with GDM to achieve better blood glucose control and reduce the rate of serious complications for themselves and their infants. Potential subjects will be screened for GDM with a 50 gm, 1-hour glucose challenge test. Women whose 1-hour screening test result e 135 mg/dl will undergo a 100 gm, 3-hour glucose tolerance test as per American Diabetes Association (ADA) guidelines. Diagnosis of GDM will be conferred if 2 or more abnormal values are found with the 100 gm test. Women diagnosed with GDM will be eligible to enter the study and randomized into one of two groups: those who are placed on a lower carbohydrate diet (between 35-40 percent of total calories) versus a usual care (control) group. Subjects in both groups will be instructed in blood glucose self-monitoring with portable reflectance memory meters. Women will be asked to monitor their blood glucose levels 4 times daily (fasting and 1- hour after meals). Statistical analyses will be based on intention to treat. The Student's t- test for independent samples will be used to determine if there are differences in the means of continuous variables between the 2 groups, including the primary outcome variable of mean postprandial blood glucose values. The Fisher's exact test will be used to compare categorical variables, such as rates of maternal complications for women with GDM. Infant outcome measures will include birth weight and rates of complications commonly found in infants of mothers with GDM. The clinical site for the proposed study serves a population at higher risk for health disparities and for developing GDM, with patients who are primarily African-American and Hispanic. Gestational diabetes mellitus (GDM) is one of the most common pregnancy complications. Most often controlled by diet, there is little evidence as to what constitutes the best diet for a mother with GDM. This study will evaluate the impact of a lower carbohydrate diet on the health of mothers with GDM and their infants when they are compared with a "usual care diet" control group.

描述（由申请人提供）：妊娠期糖尿病（GDM）是最常见的妊娠并发症之一。为了减少并发症，治疗的目标之一是将母体血糖水平维持在尽可能接近正常范围内。对于一些患有GDM的女性，需要胰岛素来达到最佳血糖水平;然而，大多数患有GDM的女性不接受药物治疗，并且“饮食控制”。尽管如此，很少有证据表明GDM女性饮食中常量营养素的最佳组成。拟议的随机对照试验旨在验证低碳水化合物饮食将帮助GDM孕妇实现更好的血糖控制并降低自身及其婴儿严重并发症的发生率的假设。将通过50 gm、1小时葡萄糖激发试验筛选潜在受试者的GDM。根据美国糖尿病协会（ADA）指南，1小时筛查测试结果为135 mg/dl的女性将接受100 gm、3小时的葡萄糖耐量测试。如果在100 gm试验中发现2个或更多异常值，则诊断为GDM。被诊断患有GDM的女性将有资格进入研究，并随机分为两组之一：那些被置于较低碳水化合物饮食（占总热量的35- 40%）与常规护理（对照）组。将指导两组受试者使用便携式反射记忆仪进行血糖自我监测。将要求女性每天监测4次血糖水平（空腹和餐后1小时）。统计分析将基于意向治疗。将使用独立样本的Student t检验来确定两组之间连续变量的平均值是否存在差异，包括平均餐后血糖值的主要结局变量。Fisher精确检验将用于比较分类变量，例如GDM女性的母体并发症发生率。婴儿结局指标将包括出生体重和GDM母亲的婴儿常见的并发症发生率。拟议研究的临床地点服务于健康差异和发展GDM风险较高的人群，患者主要是非洲裔美国人和西班牙裔。妊娠期糖尿病（GDM）是最常见的妊娠并发症之一。大多数情况下由饮食控制，几乎没有证据表明什么是GDM母亲的最佳饮食。本研究将评估低碳水化合物饮食对GDM母亲及其婴儿健康的影响，并与“常规护理饮食”对照组进行比较。