Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes (iGDM)
C
Christina M. Scifres, MD
Primary Investigator
Enrolling By Invitation
18 years - 45 years
Female
Phase
N/A
828 participants needed
7 Locations
Brief description of study
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 of study
The prevalence of both obesity and gestational diabetes mellitus (GDM) have increased, andh is associated with adverse perinatal outcomes including fetal overgrowth, neonatalbidity, hypertensive disorders of pregnancy, and cesarean delivery. Women with GDM who areverweight and obese have higher rates of pregnancy complications when compared toweight women with GDM, which may occur in part due to suboptimal glycemic control. Theurrent recommendations for glycemic targets in pregnant women with diabetes are notgorously defined, and they far exceed the mean fasting (70.9 ±7.8 mg/dL) and 1 hour postprandial
(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 todard (fasting <95 mg/dL, 1 hr post-prandial <140 mg/dL) glycemic targets resulted inved glycemic control without increasing the risk for hypoglycemia. The Intensive
Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: Aulticenter Randomized Trial (iGDM Trial) is a large, pragmatic randomized clinical trial
designed to investigate the impact of intensive versus standard glycemic targets on perinatalutcomes in women with GDM who are overweight and obese. During the 5-year project period, aultidisciplinary team of investigators from 4 medical centers representing regions of the.S. with high rates of obesity will randomize 828 overweight and obese women with GDM toher 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 neonatalbidity 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 ofhypoglycemia in overweight and obese women with GDM, and 3) Evaluate theveness of intensive glycemic control compared with standard glycemic control asured by the incremental cost per case of neonatal morbidity and LGA birth weightvented 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 andheir infants.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Gestational Diabetes, Pregnancy, High Risk, Overweight and Obesity
-
Age: 18 years - 45 years
-
Gender: Female
Inclusion Criteria:
- Pregnant women between the ages of 18-45
- Singleton gestation
- Gestational age between 12 0/7-32 0/7 weeks' gestation with gestational diabetesdiagnosed during this time frame using either a 50g 1-hr GCT ≥200 mg/dL or two or morebnormal 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 inAsian Americans)
Exclusion Criteria:
- Inability or unwillingness to provide informed consent
- Inability to communicate with members of the study team, despite the presence of an
- 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 includeuch as gastroschisis, spina bifida, complex congenital heart disease, orus karyotypic anomalies that may lead to early delivery or increased risk ofdeath)
- Oral or IV/IM steroid use within 7 days of study enrollment
Updated on
01 Aug 2024.
Study ID: 11435
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