Gestational Diabetes Mellitus Trial (GDM)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus

Conditions
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Diabetes, Gestational

Intervention / Treatment
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* Behavioral: nutritional counseling
* Behavioral: self blood glucose monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutritional counseling & self blood glucose monitoring<br>Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. | Behavioral: nutritional counseling<br> <br> Behavioral: self blood glucose monitoring<br> <br> |
| No Intervention: No treatment<br>This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Composite Neonatal Morbidity | The composite perinatal outcome included stillbirth, neonatal death, hypoglycemia, hyperbilirubinemia, elevated cordblood C-peptide level, and birth trauma. | Delivery through discharge of infant from hospital up to 120 days | 
| Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex | Number of children with BMI ≥ 95th percentile for age and sex. BMI is measured as kg / m^2. Standards based on the 2000 Centers for Disease Control growth charts. | Age 5-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Neonates Who Were Large for Gestational Age at Delivery |  | From time of randomization through delivery (up to 17 weeks) | 
| Number of Neonates With Macrosomia (Birth Weight > 4000 gm) |  | Assessed at Delivery | 
| Number Participants Who Delivered Preterm | Number of preterm deliveries before 37 weeks gestation | Delivery before 37 weeks gestation | 
| Mean Neonatal Fat Mass at Delivery |  | Assessed at delivery | 
| Number of Neonates Who Were Small for Gestational Age | Birth weight below the 10th percentile | From time of randomization through delivery (up to 17 weeks) | 
| Mean Neonatal Birth Weight | Birth weight in grams | Assessed at delivery | 
| Number of Infants Admitted to NICU | Admission to the Neonatal Intensive Care Unit | Delivery through hospital discharge up to 120 days | 
| Number of Neonates Who Received Intravenous Glucose Treatment | Number of neonates who received intravenous glucose treatment at any time from delivery through hospital discharge. | Delivery through hospital discharge up to 120 days | 
| Number of Neonates Who Experienced Respiratory Distress Syndrome | Number of neonates who experienced Respiratory Distress Syndrome at any time from delivery through hospital discharge | Delivery through hospital discharge up to 120 days | 
| Number of Participants Who Underwent Labor Induction | Number of participants who underwent labor induction | From time of randomization through induction (up to 17 weeks) | 
| Number of Participants Who Underwent Cesarean Delivery | Delivery by cesarean section | Delivery | 
| Number of Neonates Who Experienced Shoulder Dystocia | Number of neonates who experienced shoulder dystocia during labor and delivery | During the process of labor through delivery | 
| Number of Participants Who Experienced Preeclampsia | Number of participants who experienced preeclampsia | From time of randomization through delivery (up to 17 weeks) | 
| Number of Participants Who Had Preeclampsia or Gestational Hypertension | Number of participants who had Preeclampsia or gestational hypertension | From time of randomization through delivery (up to 17 weeks) | 
| Mean Maternal Body-mass Index at Delivery | Mean maternal body-mass index at the time of delivery | Delivery | 
| Mean Maternal Weight Gain | Mean Maternal weight gain from enrollment in the trial until delivery | From time of randomization through delivery (up to 17 weeks) | 
| Number of Children With BMI ≥ 85th Percentile for Age and Sex | Number of children with BMI ≥ 85th percentile for age and sex at the 5-10 year follow-up. BMI is measured as kg/m^2. Standards base on the 2000 Centers for Disease Control growth charts. | Age 5-10 years | 
| Number of Children at 5-10 Year Follow up With Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity | Child waist circumference >90th percentile for age, sex and race/ethnicity based on a study examining cross-sectional data from the Third National Health and Nutrition Examination Survey (NHANES III) | Age 5-10 years | 
| Number of Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height | Hypertension ≥ 95th percentile for age, sex and height based on the National Heart, Lung and Blood Institute Expert Panel on Integrated Guidelines for Children and Adolescents. | Age 5 - 10 years | 
| Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL | Number of children at 5-10 year follow-up with impaired fasting glucose ≥100 mg/dL | Age 5-10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild gestational diabetes mellitus, Maternal Fetal Medicine Units Network