Study of Lipid Metabolism in Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Cholesterol
研究概览
简要总结
The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics. If a difference is noted, further studies will explore the possibility of screening gestational diabetics during their pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction and placental disease will be explored.
This will be a prospective cohort study. As part of routine prenatal care, women receive a one hour glucose challenge test to screen for gestational diabetes. Those women with elevated values then require a three hour glucose tolerance test, which is a diagnostic test for gestational diabetes. All women that are scheduled to receive a three hour GTT will be identified and ask to enroll in this study. 46 women whose three hour GTT is normal and thus do not have GDM, will be compared to 46 women with an abnormal three hour GTT and thus would have the diagnosis of GDM. Enrolled women will have a lipid panel consisting of; total cholesterol, triglycerides, HDL and LDL cholesterol at the time of their fasting glucose blood sample. In addition, a repeat lipid panel will be sent at the time of the third hour sample, to assess changes, if any due to the glucose challenge. Umbilical cord blood samples will be sent in order to obtain newborn lipid profiles. Women in both the GDM and normal groups will be asked to return 6-8 weeks
详细描述
The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics. If a difference is noted, further studies will explore the possibility of screening gestational diabetics during their pregnancy for hyperlipidemia to determine if prenatal screening can predict postpartum risk for hyperlipidemia. In addition the relationship, if any between maternal lipid dysfunction and placental disease will be explored. Subsequent studies could also explore the possible perinatal complications associated with elevated lipids and or metabolic syndrome.
C. Experimental Design, Methodology and Expected Results
Study Design:
We propose a prospective cohort design.
Study Population:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnancy
- •Abnormal one hour glucose challenge test
- •"Normal" controls group one hour test between 135 mg% and 150 mg%
- •"Gestational diabetic" group with two abnormal values on a 3 hour GTT
排除标准
- •History of diagnosis of diabetes, hypertension, heart disease or chronic renal disease
- •Prior history of lipid disorder or metabolic syndrome
- •Current medications thought to adversely influence glucose tolerance (i.e. prednisone or other steroids and systemic beta-mimetic drugs)
- •Non-singleton pregnancy
- •< 16 years of age or over 40 years of age
- •Not planning to deliver at Baystate Medical Center
结局指标
主要结局
Cholesterol
时间窗: Postpartum
Cholesterol values were obtained at least 6 weeks postpartum from the gestational diabetic group and the normal controls
次要结局
- Triglyceride Values(Postpartum)
- HDL(Postpartum)
- LDL(Postpartum)
研究者
Glenn Markenson
Director, Maternal Fetal Medicine
Baystate Medical Center