Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

Indiana University828 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

828

Conditions

Gestational Diabetes Pregnancy, High Risk Overweight and Obesity

Interventions

Intensive glycemic targetsOTHER

Fasting blood glucose \<90 mg/dL, 1 hour post-prandial blood glucose \<120 mg/dL

Standard glycemic targetsOTHER

Fasting blood glucose \<95 mg/dL, 1 hour post-prandial blood glucose \<140 mg/dL

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (5)

University of Alabama at Birmingham

Birmingham, Alabama, United States

RECRUITING

Indiana University

Indianapolis, Indiana, United States

RECRUITING

University of Oklahoma

Norman, Oklahoma, United States

Outcomes

Primary Outcomes

Number of participants with composite neonatal morbidity

Composite of large for gestational age birth weight, neonatal hypoglycemia, neonatal jaundice, and neonatal respiratory distress syndrome

Time frame: Within 7 days of delivery

Secondary Outcomes

Number of participants with large for gestational age birth weight

≥90th percentile birth weight for gestational age, based on US birth weight normograms

Time frame: Birth

Number of participants with neonatal hypoglycemia

Blood glucose \<40 mg/dL in the 1st 24 hours of life

Time frame: Within 24 hours of delivery

Number of participants with neonatal jaundice

Documentation of need for phototherapy

Time frame: Within 7 days of delivery

Number of participants with respiratory distress syndrome

Signs of respiratory distress (tachypnea, grunting, nasal flaring, cyanosis) with an oxygen requirement within the first 24 hours of life and the presence of radiologic chest findings of hypoaeration and reticulogranular infiltrates or those needing immediate intubation for respiratory distress syndrome

Time frame: Within 7 days of delivery

Maternal hyperglycemia

Percent of maternal glucose values ≥120 and ≥140 mg/dL from randomization through delivery

Time frame: From randomization to delivery

Early maternal glycemic levels

Mean fasting and post-prandial values in the 7 days after randomization

Central Contacts

Sarah Oswalt

CONTACT

(317)944-7069 seoswalt@iu.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.