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Gestational Diabetes Mellitus Trial (GDM) (GDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00069576
Recruitment Status : Completed
First Posted : September 30, 2003
Results First Posted : May 31, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

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.

Condition or disease Intervention/treatment Phase
Diabetes, Gestational Behavioral: nutritional counseling Behavioral: self blood glucose monitoring Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus
Study Start Date : October 2002
Actual Primary Completion Date : November 2007
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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.
Behavioral: nutritional counseling
Behavioral: self blood glucose monitoring
No Intervention: No treatment
This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Number of Neonates Who Were Large for Gestational Age at Delivery [ Time Frame: From time of randomization through delivery (up to 17 weeks) ]
  2. Number of Neonates With Macrosomia (Birth Weight > 4000 gm) [ Time Frame: Assessed at Delivery ]
  3. Number Participants Who Delivered Preterm [ Time Frame: Delivery before 37 weeks gestation ]
    Number of preterm deliveries before 37 weeks gestation

  4. Mean Neonatal Fat Mass at Delivery [ Time Frame: Assessed at delivery ]
  5. 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

  6. Mean Neonatal Birth Weight [ Time Frame: Assessed at delivery ]
    Birth weight in grams

  7. Number of Infants Admitted to NICU [ Time Frame: Delivery through hospital discharge up to 120 days ]
    Admission to the Neonatal Intensive Care Unit

  8. 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.

  9. 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

  10. 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

  11. Number of Participants Who Underwent Cesarean Delivery [ Time Frame: Delivery ]
    Delivery by cesarean section

  12. 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

  13. Number of Participants Who Experienced Preeclampsia [ Time Frame: From time of randomization through delivery (up to 17 weeks) ]
    Number of participants who experienced preeclampsia

  14. 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

  15. Mean Maternal Body-mass Index at Delivery [ Time Frame: Delivery ]
    Mean maternal body-mass index at the time of delivery

  16. 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

  17. 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.

  18. 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)

  19. 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.

  20. 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


Other Outcome Measures:
  1. Mean Gestational Age at Birth [ Time Frame: Delivery ]
    Mean Gestational age at the time of delivery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00069576


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Wayne State University - Hutzel Hospital
Detroit, Michigan, United States, 48201
United States, New York
Columbia University-St. Luke's Hospital
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 17599
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44109
Ohio State University Hospital
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
University of Texas Medical Branch
Galveston, Texas, United States, 77555
University of Texas-Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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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)
Principal Investigator: Elizabeth A Thom, Ph.D. George Washington University Biostatistics Center

Additional Information:
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT00069576     History of Changes
Other Study ID Numbers: HD36801 - GDM
U10HD021410 ( U.S. NIH Grant/Contract )
U10HD027869 ( U.S. NIH Grant/Contract )
U10HD027917 ( U.S. NIH Grant/Contract )
U10HD027915 ( U.S. NIH Grant/Contract )
U10HD034116 ( U.S. NIH Grant/Contract )
U10HD034208 ( 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 )
U10HD036801 ( U.S. NIH Grant/Contract )
U10HD053118 ( U.S. NIH Grant/Contract )
U10HD053097 ( U.S. NIH Grant/Contract )
U10HD027860 ( U.S. NIH Grant/Contract )
U10HD034136 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2003    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: July 15, 2019
Last Verified: July 2019
Keywords provided by The George Washington University Biostatistics Center:
Mild gestational diabetes mellitus
Maternal Fetal Medicine Units Network
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications