Gestational diabetes mellitus (GDM) is a type of diabetes (high blood sugar) that occurs in pregnant women. This study will determine whether treating pregnant women with mild GDM improves the health of their babies.

Condition	Treatment or Intervention
Diabetes, Gestational	Behavior: nutritional counseling  Behavior: self blood glucose monitoring

Further Study Details: 

Expected Total Enrollment:  2375

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.

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria

• Pregnant
• Gestational age at enrollment <= 30 weeks 6 days

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

Catherine Y. Spong      301-435-6894 
Mark B. Landon      614-293-8513 

Alabama
      University of Alabama - Birmingham, Birmingham,  Alabama,  United States; Recruiting
Illinois
      Northwestern University, Chicago,  Illinois,  United States; Recruiting
Michigan
      Wayne State University - Hutzel Hospital, Detroit,  Michigan,  United States; Recruiting
New York
      Columbia University-St. Luke’s Hospital, New York City,  New York,  United States; Recruiting
North Carolina
      Wake Forest University, Winston Salem,  North Carolina,  United States; Recruiting
      University of North Carolina-Chapel Hill, Chapel Hill,  North Carolina,  United States; Recruiting
Ohio
      Ohio State University Hospital, Columbus,  Ohio,  43210,  United States; Recruiting
      Ohio State University, Columbus,  Ohio,  United States; Recruiting
      Case Western Reserve University, Cleveland,  Ohio,  United States; Recruiting
Pennsylvania
      University of Pittsburgh-Magee Womens Hospital, Pittsburgh,  Pennsylvania,  United States; Recruiting
      Drexel University, Philadelphia,  Pennsylvania,  United States; Recruiting
Rhode Island
      Brown University, Providence,  Rhode Island,  United States; Recruiting
Texas
      University of Texas-Southwestern, Dallas,  Texas,  United States; Recruiting
      University of Texas-Houston, Houston,  Texas,  United States; Recruiting
Utah
      University of Utah, Salt Lake City,  Utah,  United States; Recruiting

Study chairs or principal investigators

Mark B. Landon, MD,  Study Chair,  Ohio State University   

Study ID Numbers:  2U10HD027915
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  September 29, 2003
ClinicalTrials.gov Identifier:  NCT00069576
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08