This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Gestational diabetes mellitus is defined as carbohydrates intolerance of variable severity, which is first recognized during pregnancy. This definition applies regardless of insulin use for treatment or persistence of the condition after pregnancy, and does not exclude the possibility that unrecognized diabetes may have preceded the pregnancy. It is known that pre-existing diabetes substantially contributes to perinatal morbidity and mortality. While it is likely that maternal carbohydrate intolerance reflects a continuum of risk for adverse outcomes, it is not known whether there is a benefit to identification and subsequent treatment of mild carbohydrate intolerance during pregnancy. To determine whether mild gestational diabetes is a risk factor for adverse perinatal outcome and whether there is utility in identifying and treating patients with mild disease, a randomized clinical trial is proposed of patients with gestational diabetes who have normal fasting glucose level. The study will compare patients who have been randomized to diet therapy with patients who have been randomized to no diet therapy. A non-diabetic control group, who have an abnormal 50 gram glucose test but do not have gestational diabetes based on a traditional three hour oral glucose tolerance test, will be matched for confounding variables with the mild gestational diabetic patients in the trial. Patients who have been randomized to no dietary treatment will be indistinguished from the non-diabetic control group. This will minimize the confounding influence of obstetrical or medical intervention. All patients will undergo a standard 3-hour OGTT, umbilical cord blood obtained at delivery, infant blood obtained via heelstick and neonatal anthropometric measurements. Those women randomized to diet therapy will also perform glucometer testing four times daily until delivery and be seen weekly.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-44
Application #
7377994
Study Section
Special Emphasis Panel (ZRR1-CR-1 (01))
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
44
Fiscal Year
2006
Total Cost
$21,441
Indirect Cost
Name
Case Western Reserve University
Department
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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Tita, Alan T N; Lai, Yinglei; Landon, Mark B et al. (2017) Predictive Characteristics of Elevated 1-Hour Glucose Challenge Test Results for Gestational Diabetes. Am J Perinatol 34:1464-1469
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