Gestational Diabetes Mellitus Trial (GDM)

Diabetes, Gestational Clinical Trial

— GDM  

Official title:

A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069576
• Other study ID #: HD36801 - GDM
• Secondary ID: U10HD021410U10HD
• Status: Completed
• Phase: N/A
• Start date: October 2002
• Est. completion date: October 2013

Study information

• Verified date: July 2019
• Source: The George Washington University Biostatistics Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7381
• Est. completion date: October 2013
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational

Intervention

Behavioral:
• nutritional counseling

• self blood glucose monitoring

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of North Carolina-Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Ohio State University Hospital	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Wayne State University - Hutzel Hospital	Detroit	Michigan
United States	University of Texas Medical Branch	Galveston	Texas
United States	University of Texas-Houston	Houston	Texas
United States	Columbia University-St. Luke's Hospital	New York	New York
United States	Drexel University	Philadelphia	Pennsylvania
United States	University of Pittsburgh-Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Brown University	Providence	Rhode Island
United States	University of Utah	Salt Lake City	Utah
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
The George Washington University Biostatistics Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (21)

Bahado-Singh RO, Mele L, Landon MB, Ramin SM, Carpenter MW, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-fetal Medicine Units Network. Fetal male gender and the benefits of treatment of mild gestational diabetes mellitus. Am J Obstet Gynecol. 2012 May;206(5):422.e1-5. doi: 10.1016/j.ajog.2012.03.015. Epub 2012 Mar 23. — View Citation

Berggren EK, Mele L, Landon MB, Spong CY, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Perinatal outcomes in Hispanic and non-Hispanic white women with mild gestational diabetes. Obstet Gynecol. 2012 Nov;120(5):1099-104. doi: http://10.1097/AOG.0b013e31827049a5. — View Citation

Blackwell SC, Landon MB, Mele L, Reddy UM, Casey BM, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Saade G, Caritis SN, Sorokin Y, Grobman WA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Relationship Between Excessive Gestational Weight Gain and Neonatal Adiposity in Women With Mild Gestational Diabetes Mellitus. Obstet Gynecol. 2016 Dec;128(6):1325-1332. — View Citation

Casey BM, Mele L, Landon MB, Spong CY, Ramin SM, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Catalano P, Harper M, Saade G, Sorokin Y, Peaceman AM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Does maternal body mass index influence treatment effect in women with mild gestational diabetes? Am J Perinatol. 2015 Jan;32(1):93-100. doi: 10.1055/s-0034-1374815. Epub 2014 May 16. — View Citation

Catalano PM, Mele L, Landon MB, Ramin SM, Reddy UM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Saade G, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Inadequate weight gain in overweight and obese pregnant women: what is the effect on fetal growth? Am J Obstet Gynecol. 2014 Aug;211(2):137.e1-7. doi: 10.1016/j.ajog.2014.02.004. Epub 2014 Feb 11. — View Citation

Costantine MM, Mele L, Landon MB, Spong CY, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, Maryland. Customized versus population approach for evaluation of fetal overgrowth. Am J Perinatol. 2013 Aug;30(7):565-72. doi: 10.1055/s-0032-1329188. Epub 2012 Nov 12. — View Citation

Durnwald CP, Mele L, Spong CY, Ramin SM, Varner MW, Rouse DJ, Sciscione A, Catalano P, Saade G, Sorokin Y, Tolosa JE, Casey B, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Glycemic characteristics and neonatal outcomes of women treated for mild gestational diabetes. Obstet Gynecol. 2011 Apr;117(4):819-27. doi: 10.1097/AOG.0b013e31820fc6cf. — View Citation

Figueroa D, Landon MB, Mele L, Spong CY, Ramin SM, Casey B, Wapner RJ, Varner MW, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Relationship between 1-hour glucose challenge test results and perinatal outcomes. Obstet Gynecol. 2013 Jun;121(6):1241-7. doi: 10.1097/AOG.0b013e31829277f5. — View Citation

Harper LM, Mele L, Landon MB, Carpenter MW, Ramin SM, Reddy UM, Casey B, Wapner RJ, Varner MW, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Carpenter-Coustan Compared With National Diabetes Data Group Criteria for Diagnosing Gestational Diabetes. Obstet Gynecol. 2016 May;127(5):893-8. doi: 10.1097/AOG.0000000000001383. — View Citation

Landon MB, Mele L, Spong CY, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health, and Human Development (NICHD) Maternal–Fetal Medicine Units (MFMU) Network. The relationship between maternal glycemia and perinatal outcome. Obstet Gynecol. 2011 Feb;117(2 Pt 1):218-24. — View Citation

Landon MB, Rice MM, Varner MW, Casey BM, Reddy UM, Wapner RJ, Rouse DJ, Biggio JR Jr, Thorp JM, Chien EK, Saade G, Peaceman AM, Blackwell SC, VanDorsten JP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Med — View Citation

Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Ch — View Citation

Landon MB, Thom E, Spong CY, Gabbe SG, Leindecker S, Johnson F, Lain K, Miodovnik M, Carpenter M. A planned randomized clinical trial of treatment for mild gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2002 Apr;11(4):226-31. — View Citation

Ma KK, Mele L, Landon MB, Spong CY, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. The obstetric and neonatal implications of a low value on the 50-g glucose screening test. Am J Perinatol. 2013 Oct;30(9):715-22. doi: 10.1055/s-0032-1331027. Epub 2012 Dec 27. — View Citation

Palatnik A, Mele L, Landon MB, Reddy UM, Ramin SM, Carpenter MW, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Saade GR, Caritis SN, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Timing of treatment initiation for mild gestational diabetes mellitus and perinatal outcomes. Am J Obstet Gynecol. 2015 Oct;213(4):560.e1-8. doi: 10.1016/j.ajog.2015.06.022. Epub 2015 Jun 11. — View Citation

Rice MM, Landon MB, Varner MW, Casey BM, Reddy UM, Wapner RJ, Rouse DJ, Biggio JR Jr, Thorp JM Jr, Chien EK, Saade G, Peaceman AM, Blackwell SC, VanDorsten JP; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Pregnancy-Associated Hypertension in Glucose-Intolerant Pregnancy and Subsequent Metabolic Syndrome. Obstet Gynecol. 2016 Apr;127(4):771-9. doi: 10.1097/AOG.0000000000001353. — View Citation

Stuebe AM, Landon MB, Lai Y, Klebanoff M, Ramin SM, Wapner RJ, Varner MW, Rouse DJ, Sciscione A, Catalano P, Saade G, Sorokin Y, Peaceman AM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, MD. Is There a Threshold Oral Glucose Tolerance Test Value for Predicting Adverse Pregnancy Outcome? Am J Perinatol. 2015 Jul;32(9):833-8. doi: 10.1055/s-0034-1543949. Epub 2015 Jan 16. — View Citation

Stuebe AM, Landon MB, Lai Y, Spong CY, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Sciscione A, Catalano P, Harper M, Saade G, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Bethesda, MD. Maternal BMI, glucose tolerance, and adverse pregnancy outcomes. Am J Obstet Gynecol. 2012 Jul;207(1):62.e1-7. doi: 10.1016/j.ajog.2012.04.035. Epub 2012 May 2. — View Citation

Sutton AL, Mele L, Landon MB, Ramin SM, Varner MW, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Grobman WA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Delivery timing and cesarean delivery risk in women with mild gestational diabetes mellitus. Am J Obstet Gynecol. 2014 Sep;211(3):244.e1-7. doi: 10.1016/j.ajog.2014.03.005. Epub 2014 Mar 4. — View Citation

Tita ATN, Lai Y, Landon MB, Ramin SM, Casey B, Wapner RJ, Varner MW, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade GR, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Predictive Characteristics of Elevated 1-Hour Glucose Challenge Test Results for Gestational Diabetes. Am J Perinatol. 2017 Dec;34(14):1464-1469. doi: 10.1055/s-0037-1604243. Epub 2017 Jul 19. — View Citation

Varner MW, Rice MM, Landon MB, Casey BM, Reddy UM, Wapner RJ, Rouse DJ, Tita AT, Thorp JM, Chien EK, Saade GR, Peaceman AM, Blackwell SC, Vandorsten JP; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Pregnancies After the Diagnosis of Mild Gestational Diabetes Mellitus and Risk of Cardiometabolic Disorders. Obstet Gynecol. 2017 Feb;129(2):273-280. doi: 10.1097/AOG.0000000000001863. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Gestational Age at Birth	Mean Gestational age at the time of delivery	Delivery
Primary	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
Primary	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	Number of Neonates Who Were Large for Gestational Age at Delivery		From time of randomization through delivery (up to 17 weeks)
Secondary	Number of Neonates With Macrosomia (Birth Weight > 4000 gm)		Assessed at Delivery
Secondary	Number Participants Who Delivered Preterm	Number of preterm deliveries before 37 weeks gestation	Delivery before 37 weeks gestation
Secondary	Mean Neonatal Fat Mass at Delivery		Assessed at delivery
Secondary	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)
Secondary	Mean Neonatal Birth Weight	Birth weight in grams	Assessed at delivery
Secondary	Number of Infants Admitted to NICU	Admission to the Neonatal Intensive Care Unit	Delivery through hospital discharge up to 120 days
Secondary	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
Secondary	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
Secondary	Number of Participants Who Underwent Labor Induction	Number of participants who underwent labor induction	From time of randomization through induction (up to 17 weeks)
Secondary	Number of Participants Who Underwent Cesarean Delivery	Delivery by cesarean section	Delivery
Secondary	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
Secondary	Number of Participants Who Experienced Preeclampsia	Number of participants who experienced preeclampsia	From time of randomization through delivery (up to 17 weeks)
Secondary	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)
Secondary	Mean Maternal Body-mass Index at Delivery	Mean maternal body-mass index at the time of delivery	Delivery
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   NICHD Maternal Fetal Medicine Units Network website