Clinical trial NCT05124808: Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
Official title: Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes Mellitus: A Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Pregnancy, High Risk
Overweight and Obesity
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: University of Alabama at Birmingham
name: University of Oklahoma
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Women and Infants Hospital of Rhode Island
First posted: 2021-11-18
Enrollment: 828
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.

Detailed description: The prevalence of both obesity and gestational diabetes mellitus (GDM) have increased, and each is associated with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of pregnancy, and cesarean delivery. Women with GDM who are also overweight and obese have higher rates of pregnancy complications when compared to normal weight women with GDM, which may occur in part due to suboptimal glycemic control. The current recommendations for glycemic targets in pregnant women with diabetes are not rigorously defined, and they far exceed the mean fasting (70.9 ±7.8 mg/dL) and 1 hour post- prandial (108.9 ± 12.9 mg/dL) glucose values in pregnant women without GDM. Our prior work demonstrated that use of intensive (fasting \<90, 1 hr post-prandial \<120 mg/dL) compared to standard (fasting \<95 mg/dL, 1 hr post-prandial \<140 mg/dL) glycemic targets resulted in improved glycemic control without increasing the risk for hypoglycemia. The Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial (iGDM Trial) is a large, pragmatic randomized clinical trial designed to investigate the impact of intensive versus standard glycemic targets on perinatal outcomes in women with GDM who are overweight and obese. During the 5-year project period, a multidisciplinary team of investigators from 4 medical centers representing regions of the U.S. with high rates of obesity will randomize 828 overweight and obese women with GDM to either intensive or standard glycemic targets. The specific aims of this project are: 1) Determine the effectiveness of intensive glycemic targets in reducing the risk for neonatal composite morbidity and large for gestational age birthweight in overweight and obese women with GDM, 2) Assess the safety of intensive glycemic targets as measured by the frequency of maternal hypoglycemia in overweight and obese women with GDM, and 3) Evaluate the cost-effectiveness of intensive glycemic control compared with standard glycemic control as measured by the incremental cost per case of neonatal morbidity and LGA birth weight prevented and per Quality-adjusted Life-year. The expected outcome of this study is high-quality evidence on the effectiveness, safety, and cost-effectiveness of intensive glycemic targets in reducing adverse perinatal outcomes among overweight and obese women with GDM. If proven effective, use of intensive glycemic targets in overweight and obese women with GDM will have an important positive impact on the health of these high risk women and their infants.

Eligibility criteria: Inclusion Criteria:

* Pregnant women between the ages of 18-45
* Singleton gestation
* Gestational age between 12 0/7-32 6/7 weeks' gestation with gestational diabetes diagnosed during this time frame using either a 50g 1-hr GCT ≥200 mg/dL or two or more abnormal values on a 100g OGTT using the Carpenter-Coustan Criteria
* Overweight or obese BMI at the first prenatal visit (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans)

Exclusion Criteria:

* Inability or unwillingness to provide informed consent
* Inability to communicate with members of the study team, despite the presence of an interpreter
* Planned delivery at a non-study affiliated hospital
* Known renal disease with a baseline creatinine \>1.5 mg/dL
* Significant fetal anomalies diagnosed prior to study enrollment (these will include anomalies such as gastroschisis, spina bifida, complex congenital heart disease, or serious karyotypic anomalies that may lead to early delivery or increased risk of neonatal death)
* Oral or IV/IM steroid use within 7 days of study enrollment

Primary outcomes:
measure: Number of participants with composite neonatal morbidity
timeFrame: Within 7 days of delivery
Secondary outcomes:
measure: Number of participants with large for gestational age birth weight
timeFrame: Birth
measure: Number of participants with neonatal hypoglycemia
timeFrame: Within 24 hours of delivery
measure: Number of participants with neonatal jaundice
timeFrame: Within 7 days of delivery
measure: Number of participants with respiratory distress syndrome
timeFrame: Within 7 days of delivery
measure: Maternal hyperglycemia
timeFrame: From randomization to delivery
measure: Early maternal glycemic levels
timeFrame: 7 days after randomization
measure: Pre-delivery maternal glycemic levels
timeFrame: 14 days prior to delivery
measure: Glycemic levels during study enrollment
timeFrame: Up to 29 weeks
measure: Episodes of maternal hypoglycemia
timeFrame: From randomization to delivery
measure: Number of episodes of symptomatic maternal hypoglycemia
timeFrame: From randomization to delivery
measure: Number of participants with hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia)
timeFrame: From randomization up to 30 days after delivery
measure: Number of participants with small for gestational age birth weight
timeFrame: Birth
measure: Number of participants with cesarean delivery
timeFrame: Delivery
measure: Number of participants with preterm birth <37 weeks
timeFrame: Delivery
measure: Number of participants with shoulder dystocia
timeFrame: Delivery
measure: Number of participants with NICU admission
timeFrame: Within 7 days of delivery
measure: Infant adiposity
timeFrame: Within 72 hours of delivery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Norman
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Women and Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Indiana University
name: Christina Scifres, MD
role: PRINCIPAL_INVESTIGATOR
References: