EFFECTS OF PREGNANCY ON DIABETIC MICROVASCULAR DISEASE

妊娠对糖尿病微血管疾病的影响

• 批准号: 3857397
• 负责人: MICHAEL A BERK
• 金额: --
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3857397
• 关键词: blood glucose; diabetes mellitus therapy; diabetic angiopathy; diabetic retinopathy; disease /disorder proneness /risk; eye fundus photography; female; fluorescein angiography; gestational age; gestational diabetes mellitus; human pregnant subject; human subject; insulin; insulin dependent diabetes mellitus; longitudinal human study; patient care management; retina circulation disorder

Insulin dependent diabetic women desiring pregnancy are frequently counseled that pregnancy may worsen chronic complications of diabetes, specifically retinopathy and nephropathy. This project will study the effect of pregnancy on diabetic microvascular disease. It will test the hypothesis that pregnancy in the insulin dependent diabetic increases the progression rate of diabetic microvascular disease and determine whether the pregnant state, per se, or the theraputic measures of diabetic treatment during pregnancy, intensive insulin therapy, result in acceleration of microvascular disease manifested primarily by worsening of diabetic retinopathy. The study will involve two groups of subjects. The first group will be pregnant diabetic women enrolling in the Core Clinical Trial. The second will be a group of non-pregnant diabetic women matched for duration of diabetes and number of previous pregnancies. The latter group will be comprised primarily of women have previously participated in the Core Clinical Trial since 1978. Control subjects will have their diabetes managed in the same fashion, to the same level of glycemic control and for the same duration as their pregnant counterparts. After this period of intensive management, "the pregnant period" in both groups, each pair will be followed for two more years to examine the longer-term effects of pregnancy on diabetic microvascular disease. During the pregnant period, both groups will have detailed eye exams including fundus photography at intervals corresponding to each trimester for the pregnant subject. After pregnancy, both groups will have fluorescein angiography yearly and fundus photography every 4 months. Other pertinent measures will include glycohemoglobin (monthly during pregnancy and every two months in the follow-up period), urinary microalbumin excretion (same schedule as eye exams). Patients will also perform home glucose monitoring using "memory" reflectance meters and have regular physician visits. It is expected that pregnant diabetic patients will show an increase in the progression rate of diabetic retinopathy during pregnancy compared to controls which will be, in part, attributable to intensive insulin therapy. The follow-up period will determine if pregnancy has an independent effect on acceleration of diabetic microvascular disease and will allow health care providers to provide accurate information to diabetic women seeking pregnancy regarding long-term consequences for themselves and their families.

希望怀孕的胰岛素依赖型糖尿病妇女经常 建议怀孕可能会加重糖尿病的慢性并发症， 特别是视网膜病和肾病。本项目将研究 妊娠对糖尿病微血管病变影响它将考验 假设胰岛素依赖型糖尿病患者怀孕会增加 糖尿病微血管疾病的进展率，并确定是否 妊娠状态本身或糖尿病的治疗措施 怀孕期间的治疗、强化胰岛素治疗，导致 微血管疾病加速，主要表现为 糖尿病视网膜病变 这项研究将涉及两组受试者。第一组将是 参加核心临床试验的糖尿病孕妇。第二 将是一组非妊娠糖尿病女性， 糖尿病和以前怀孕的次数。后者将是 主要由妇女组成， 自1978年以来的临床试验。对照组的糖尿病患者 以相同的方式管理，达到相同的血糖控制水平， 和怀孕的同类一样长经过这段时间的 强化管理，“怀孕期”在两组，每对将 再跟踪两年，以检查 糖尿病微血管病变的影响。 在怀孕期间，两组都将进行详细的眼科检查 包括对应于每个三个月的间隔进行眼底照相 怀孕的实验对象怀孕后，两组都将有 每年进行一次荧光素血管造影，每4个月进行一次眼底照相。 其他相关指标将包括糖化血红蛋白（每月一次， 妊娠期和随访期每两个月一次），尿 微量白蛋白排泄（与眼科检查时间表相同）。患者也将 使用"记忆"反射仪进行家庭血糖监测， 定期的医生访问。 预计妊娠糖尿病患者将显示出增加， 妊娠期糖尿病视网膜病变的进展率与 部分归因于强化胰岛素的控制 疗法随访期将确定怀孕是否有 对糖尿病微血管疾病加速的独立作用， 将允许医疗保健提供者提供准确的信息， 寻求怀孕的糖尿病妇女对 他们自己和他们的家人。