Gestational Diabetes Mellitus Trial (GDM) (GDM)

A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

7381

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University - Hutzel Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia University-St. Luke's Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 17599
        • University of North Carolina-Chapel Hill
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Case Western Reserve University
      • Columbus, Ohio, United States, 43210
        • Ohio State University Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Drexel University
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh-Magee Womens Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Brown University
    • Texas
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical Center
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • University of Texas-Houston
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutritional counseling & self blood glucose monitoring
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.
No Intervention: No treatment
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Composite Neonatal Morbidity
Time Frame: Delivery through discharge of infant from hospital up to 120 days
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
Time Frame: Age 5-10 years
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
Time Frame: From time of randomization through delivery (up to 17 weeks)
From time of randomization through delivery (up to 17 weeks)
Number of Neonates With Macrosomia (Birth Weight > 4000 gm)
Time Frame: Assessed at Delivery
Assessed at Delivery
Number Participants Who Delivered Preterm
Time Frame: Delivery before 37 weeks gestation
Number of preterm deliveries before 37 weeks gestation
Delivery before 37 weeks gestation
Mean Neonatal Fat Mass at Delivery
Time Frame: Assessed at delivery
Assessed at delivery
Number of Neonates Who Were Small for Gestational Age
Time Frame: From time of randomization through delivery (up to 17 weeks)
Birth weight below the 10th percentile
From time of randomization through delivery (up to 17 weeks)
Mean Neonatal Birth Weight
Time Frame: Assessed at delivery
Birth weight in grams
Assessed at delivery
Number of Infants Admitted to NICU
Time Frame: Delivery through hospital discharge up to 120 days
Admission to the Neonatal Intensive Care Unit
Delivery through hospital discharge up to 120 days
Number of Neonates Who Received Intravenous Glucose Treatment
Time Frame: Delivery through hospital discharge up to 120 days
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
Time Frame: Delivery through hospital discharge up to 120 days
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
Time Frame: From time of randomization through induction (up to 17 weeks)
Number of participants who underwent labor induction
From time of randomization through induction (up to 17 weeks)
Number of Participants Who Underwent Cesarean Delivery
Time Frame: Delivery
Delivery by cesarean section
Delivery
Number of Neonates Who Experienced Shoulder Dystocia
Time Frame: During the process of labor through delivery
Number of neonates who experienced shoulder dystocia during labor and delivery
During the process of labor through delivery
Number of Participants Who Experienced Preeclampsia
Time Frame: From time of randomization through delivery (up to 17 weeks)
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
Time Frame: From time of randomization through delivery (up to 17 weeks)
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
Time Frame: Delivery
Mean maternal body-mass index at the time of delivery
Delivery
Mean Maternal Weight Gain
Time Frame: From time of randomization through delivery (up to 17 weeks)
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
Time Frame: Age 5-10 years
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
Time Frame: Age 5-10 years
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
Time Frame: Age 5 - 10 years
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
Time Frame: Age 5-10 years
Number of children at 5-10 year follow-up with impaired fasting glucose ≥100 mg/dL
Age 5-10 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Gestational Age at Birth
Time Frame: Delivery
Mean Gestational age at the time of delivery
Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mark B. Landon, MD, Ohio State University
  • Study Director: Uma Reddy, MD, MPH, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

September 29, 2003

First Submitted That Met QC Criteria

September 29, 2003

First Posted (Estimate)

September 30, 2003

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • HD36801 - GDM
  • U10HD036801 (U.S. NIH Grant/Contract)
  • U10HD021410 (U.S. NIH Grant/Contract)
  • U10HD027869 (U.S. NIH Grant/Contract)
  • U10HD027917 (U.S. NIH Grant/Contract)
  • U10HD027860 (U.S. NIH Grant/Contract)
  • U10HD034116 (U.S. NIH Grant/Contract)
  • U10HD034208 (U.S. NIH Grant/Contract)
  • U10HD034136 (U.S. NIH Grant/Contract)
  • U10HD040500 (U.S. NIH Grant/Contract)
  • U10HD040485 (U.S. NIH Grant/Contract)
  • U10HD040544 (U.S. NIH Grant/Contract)
  • U10HD040545 (U.S. NIH Grant/Contract)
  • U10HD040560 (U.S. NIH Grant/Contract)
  • U10HD040512 (U.S. NIH Grant/Contract)
  • U10HD053097 (U.S. NIH Grant/Contract)
  • U10HD027915 (U.S. NIH Grant/Contract)
  • U10HD053118 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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