Clinical trial NCT00069576: Gestational Diabetes Mellitus Trial (GDM)
Official title: A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Gestational
Keywords: Mild gestational diabetes mellitus
Maternal Fetal Medicine Units Network
Lead sponsor: The George Washington University Biostatistics Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2003-09-30
Enrollment: 7381
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 who have mild GDM improves the health of their babies. The follow-up study will examine whether factors during the previous pregnancy (such as blood sugar during pregnancy) are associated with the woman and her child's health 4-9 years later.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Composite Neonatal Morbidity
timeFrame: Delivery through discharge of infant from hospital up to 120 days
measure: Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex
timeFrame: Age 5-10 years
Secondary outcomes:
measure: Number of Neonates Who Were Large for Gestational Age at Delivery
timeFrame: From time of randomization through delivery (up to 17 weeks)
measure: Number of Neonates With Macrosomia (Birth Weight > 4000 gm)
timeFrame: Assessed at Delivery
measure: Number Participants Who Delivered Preterm
timeFrame: Delivery before 37 weeks gestation
measure: Mean Neonatal Fat Mass at Delivery
timeFrame: Assessed at delivery
measure: Number of Neonates Who Were Small for Gestational Age
timeFrame: From time of randomization through delivery (up to 17 weeks)
measure: Mean Neonatal Birth Weight
timeFrame: Assessed at delivery
measure: Number of Infants Admitted to NICU
timeFrame: Delivery through hospital discharge up to 120 days
measure: Number of Neonates Who Received Intravenous Glucose Treatment
timeFrame: Delivery through hospital discharge up to 120 days
measure: Number of Neonates Who Experienced Respiratory Distress Syndrome
timeFrame: Delivery through hospital discharge up to 120 days
measure: Number of Participants Who Underwent Labor Induction
timeFrame: From time of randomization through induction (up to 17 weeks)
measure: Number of Participants Who Underwent Cesarean Delivery
timeFrame: Delivery
measure: Number of Neonates Who Experienced Shoulder Dystocia
timeFrame: During the process of labor through delivery
measure: Number of Participants Who Experienced Preeclampsia
timeFrame: From time of randomization through delivery (up to 17 weeks)
measure: Number of Participants Who Had Preeclampsia or Gestational Hypertension
timeFrame: From time of randomization through delivery (up to 17 weeks)
measure: Mean Maternal Body-mass Index at Delivery
timeFrame: Delivery
measure: Mean Maternal Weight Gain
timeFrame: From time of randomization through delivery (up to 17 weeks)
measure: Number of Children With BMI ≥ 85th Percentile for Age and Sex
timeFrame: Age 5-10 years
measure: Number of Children at 5-10 Year Follow up With Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity
timeFrame: Age 5-10 years
measure: Number of Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height
timeFrame: Age 5 - 10 years
measure: Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL
timeFrame: Age 5-10 years
Other outcomes:
measure: Mean Gestational Age at Birth
timeFrame: Delivery
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Detroit
country: United States
facility: Wayne State University - Hutzel Hospital
state: Michigan
city: New York
country: United States
facility: Columbia University-St. Luke's Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh-Magee Womens Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Brown University
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: University of Texas-Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Ohio State University
name: Mark B. Landon, MD
role: STUDY_CHAIR
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Uma Reddy, MD, MPH
role: STUDY_DIRECTOR
affiliation: George Washington University Biostatistics Center
name: Elizabeth A Thom, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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