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Home > "G" Clinical Trials Conditions > Gestational Diabetes Mellitus Trial  Gestational Diabetes Mellitus Trial
Gestational Diabetes Mellitus Trial
For Condition: Diabetes, Gestational
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Female
Protocol Entry 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
Total Enrollment: 2375
Location and Contact Information:
Overall Study Official:
MarkLandon, Study Chair, Ohio State University
Columbia University-St. Luke’s Hospital *Recruiting*
New York City, New York,
United States
Recruiting Fergal Malone
Wayne State University - Hutzel Hospital *Recruiting*
Detroit, Michigan,
United States
Recruiting Yoram Sorokin
Northwestern University *Recruiting*
Chicago, Illinois,
United States
Recruiting Alan Peaceman
University of Texas-Southwestern *Recruiting*
Dallas, Texas,
United States
Recruiting Kenneth Leveno
Ohio State University Hospital *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Francee Johnson 614-293-5632
Drexel University *Recruiting*
Philadelphia, Pennsylvania,
United States
Recruiting Anthony Sciscione
Case Western Reserve University *Recruiting*
Cleveland, Ohio,
United States
Recruiting Brian Mercer
University of Alabama - Birmingham *Recruiting*
Birmingham, Alabama,
United States
Recruiting Dwight Rouse
University of Pittsburgh-Magee Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania,
United States
Recruiting Steve Caritis
University of Utah *Recruiting*
Salt Lake City, Utah,
United States
Recruiting Michael Varner
Wake Forest University *Recruiting*
Winston Salem, North Carolina,
United States
Recruiting Margaret Harper
University of Texas-Houston *Recruiting*
Houston, Texas,
United States
Recruiting Susan Ramin
University of North Carolina-Chapel Hill *Recruiting*
Chapel Hill, North Carolina,
United States
Recruiting John Thorp Jr.
Ohio State University *Recruiting*
Columbus, Ohio,
United States
Recruiting Jay Iams
Brown University *Recruiting*
Providence, Rhode Island,
United States
Recruiting Marshall Carpenter
Additional Information:
Study ID Numbers: 2U10HD027915;
Study Start Date: October 2002
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069576
Other Diabetes, Gestational Studies:
1. Gestational Diabetes Mellitus Trial
Related Studies:
Other Diabetes, Gestational Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Gestational Diabetes Mellitus Trial
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