Indiana University
This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.
The prevalence of both obesity and gestational diabetes mellitus (GDM) have increased, and each is associated with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of pregnancy, and cesarean delivery. Women with GDM who are also overweight and obese have higher rates of pregnancy complications when compared to normal weight women with GDM, which may occur in part due to suboptimal glycemic control. The current recommendations for glycemic targets in pregnant women with diabetes are not rigorously defined, and they far exceed the mean fasting (70…
Inclusion Criteria: * Pregnant women between the ages of 18-45 * Singleton gestation * Gestational age between 12 0/7-32 6/7 weeks' gestation with gestational diabetes diagnosed during this time frame using either a 50g 1-hr GCT ≥200 mg/dL or two or more abnormal values on a 100g OGTT using the Carpenter-Coustan Criteria * Overweight or obese BMI at the first prenatal visit (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans) Exclusion Criteria: * Inability or unwillingness to provide informed consent * Inability to communicate with members of the study team, despite the presence of an interpret…
Fasting blood glucose \<90 mg/dL, 1 hour post-prandial blood glucose \<120 mg/dL
Fasting blood glucose \<95 mg/dL, 1 hour post-prandial blood glucose \<140 mg/dL
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