跳至主要内容
临床试验/NCT06067685
NCT06067685招募中不适用

Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
44
试验地点
1
主要终点
Correlation coefficient between triglyceride levels and birthweight

研究概览

简要总结

This is a prospective, observational study which examines the association between maternal triglycerides in the antepartum period and fetal overgrowth in pregnancies complicated by gestational diabetes. Mothers are asked to provide 2 blood samples, undergo fingerstick blood measurements, and to have their newborns measured for body fat composition in the first 6 months of life.

详细描述

Gestational diabetes (GDM) is a condition of impaired insulin resistance which causes increased morbidity for mothers and newborns due to fetal overgrowth. Traditionally, GDM is diagnosed with a glucose tolerance test, and treatment subsequently focuses singularly on glucose management. However, both glucose and triglycerides (TAG) are fuels for fetal overgrowth. The central hypothesis is that the most effective understanding of fetal overgrowth needs to include both carbohydrates and triglycerides. The study will focus recruitment on patients who have GDM and BMI > 35. The specific aims are 1) Determine the relationship between TAG levels during pregnancy and offspring size, 2) Explore the relationship between TAG levels during pregnancy and adipose tissue accrual (birth weight, body composition and adipose tissue distribution) from birth to six months old, and 3)Examine the relationship between maternal TAG levels and cord c-peptide levels. Mothers are asked to check their serum triglycerides at the time of diagnosis of GDM and at the end of pregnancy. Fingerstick blood measurements of triglycerides are also measured every 2 weeks at prenatal visits. At delivery, cord blood is collected. Infants are examined at 0.5, 3, and 6 months after birth.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • singleton pregnancy
  • diagnosis of GDM between 24-32 weeks
  • BMI >= 30

排除标准

  • Conditions known to impact fetal growth.These conditions can develop after study enrollment but cannot be present at enrollment.
  • autoimmune conditions treated with medication
  • chronic hypertension requiring medication
  • preeclampsia
  • fetal growth restriction diagnosis
  • illicit drug use
  • major fetal anomalies
  • fetal genetic conditions

结局指标

主要结局

Correlation coefficient between triglyceride levels and birthweight

时间窗: Newborn Day of Life 0

Correlation coefficient

次要结局

  • Correlation coefficient between triglyceride levels and total fat mass(0.5, 3, and 6 months)
  • Correlation coefficient between triglyceride levels and cord c-peptide levels(Newborn Day of Life 0)
  • Correlation coefficient between triglyceride levels and body fat distribution(0.5, 3, and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gene Lee, MD

Assistant Professor

University of Kansas Medical Center

研究点 (1)

Loading locations...

相似试验