Gestational Diabetes Mellitus Trial (GDM)

Gestational diabetes mellitus is defined as glucose intolerance of variable severity with
onset or first recognition during pregnancy. The definition applies regardless of insulin use
for treatment or the persistence of the condition after pregnancy, and does not exclude the
possibility that unrecognized glucose intolerance or overt diabetes may have preceded the
pregnancy. Pre-existing diabetes substantially contributes to perinatal morbidity and
mortality. The association of milder forms of gestational diabetes with adverse pregnancy
outcomes, including morbidities such as macrosomia, birth trauma, and neonatal hypoglycemia,
remains questionable. While it is likely that maternal glucose intolerances reflect a
continuum of risk for adverse outcomes, it is not known whether there is a benefit to
identification and subsequent treatment of mild glucose intolerance during pregnancy. This
study will determine whether dietary treatment (and insulin as required) for mild GDM will
reduce the frequency of neonatal morbidity associated with mild glucose intolerance.

Participants in this study will receive a 50-gram glucose loading test (GLT) between 24 and
30 weeks' gestation. Those with a positive GLT will receive a subsequent 3-hour oral glucose
tolerance test (OGTT). Based upon these test results, women will be assigned to 4 groups.
Women with a positive GLT and abnormal OGTT will be randomly assigned to receive either
nutritional counseling and diet therapy (Group 1) or no specific treatment (Group 2a). Women
with a positive GLT but normal OGTT will be enrolled in Group 2b for observation. Women with
a negative GLT will be enrolled in Group 3 and will serve as a control group.

Women in Group 1 will receive formal nutritional counseling and will be instructed on the
techniques of self blood glucose monitoring. Patients will take daily blood glucose
measurements and will be seen at weekly study visits. The study will evaluate birth outcomes,
including stillbirth, neonatal hypoglycemia, neonatal hyperinsulinemia, neonatal
hyperbilirubinemia, and birth trauma.

The follow-up study will examine if blood sugar levels and treatments during pregnancy
influence the health of the mother and child several years later. The study will also examine
whether there is a genetic link to the health of the mother and child. The study visit will
include blood pressure, body size measurements, blood draw and saliva collection, and
questions related to the mother and child's health and environment.

Inclusion Criteria:

- Pregnant

- Gestational age at enrollment 24 - 31 weeks

Exclusion Criteria:

- Diabetes diagnosed prior to pregnancy

- Abnormal gestational diabetes (>= 135 mg/dl) testing prior to 24 weeks' gestation

- Gestational diabetes in a previous pregnancy

- History of stillbirth or fetal death

- Pregnancy with more than one fetus

- Known major fetal anomaly

- Current or planned corticosteroid therapy

- Asthma requiring medication

- Current or planned beta adrenergic therapy

- Chronic hypertension requiring medication within 6 months of or during pregnancy

- Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart
disease

- Hematologic or autoimmune disease such as sickle cell disease, other
hemoglobinopathies, lupus, or antiphospholipid syndrome

- Maternal or fetal conditions likely to require preterm delivery, such as
pre-eclampsia, preterm labor, or intrauterine growth retardation

- Previous or planned tocolytic therapy to induce labor or increase contraction strength