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临床试验/NCT04956094
NCT04956094撤回不适用

Association of Elevated Serum Gamma Glutamyl Transferase (GGT) and Uric Acid at 9-14 Weeks Gestation With the Development of Gestational Diabetes Mellitus (GDM)

Mount Carmel Health System1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
200
试验地点
1
主要终点
Proportion of patients diagnosed with gestational diabetes mellitus

研究概览

简要总结

Gestational Diabetes Mellitus (GDM) is a common metabolic complication of pregnancy defined as new onset hyperglycemia during gestation. GDM conveys significant risk of morbidity and mortality for both mother and infant. An estimated 268,900 infants were born to mothers with GDM in the USA, accounting for approximately 6.9% of births. Although individual correlations have been found between elevated GGT and uric acid levels and later development of GDM, no research has established and validated combined criteria for GGT and uric acid levels that would lead to their use in identifying women at high risk of GDM in the first trimester.

Central Hypothesis: Serum GGT and serum uric acid collected between >9-14.0 weeks gestation will be significantly elevated in women who later develop GDM compared to those who do not. Combined analysis of serum uric acid and GGT levels within the first trimester allows for accurate prediction of the development of GDM.

Study population includes women between 9-14 weeks gestation undergoing a standard first trimester blood draw. Additional blood will be drawn during the standard blood draw to assess GGT and uric acid levels. Research participants will be tracked afterwards to determine whether they tested positive for gestational diabetes during the standard testing process which typically occurs at 24-28 weeks gestation. The data will then be analyzed to estimate the sensitivity, specificity, positive and negative predictive values of the first trimester GGT and uric acid tests. The GGT and uric acid levels which maximize the area under the receiver-operator characteristic curve will be identified.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women between > 9 weeks and < 14.0 weeks gestation

排除标准

  • Known history of or current diagnosis of type I or type II diabetes mellitus
  • Known liver disease
  • Known kidney disease
  • Known history of or current diagnosis of gout
  • Known history of alcoholism or current alcohol use
  • Multiple gestation
  • < 18 years of age

结局指标

主要结局

Proportion of patients diagnosed with gestational diabetes mellitus

时间窗: 24-28 weeks

Diagnosis of gestational diabetes mellitus (GDM) via oral glucose tolerance testing (Carpenter and Coustan criteria)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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