Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

Launched by INDIANA UNIVERSITY · Nov 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the best way to manage blood sugar levels in overweight and obese women who have been diagnosed with gestational diabetes during pregnancy. The goal is to see if having stricter blood sugar targets (intensive glycemic targets) is more effective than standard targets. The trial is currently looking for participants and aims to include 828 women who are pregnant, between the ages of 18 to 45, and have been diagnosed with gestational diabetes. To qualify, women must be overweight or obese at their first prenatal visit and be in a specific stage of pregnancy.

Participants in this study can expect to be randomly assigned to either the standard or intensive blood sugar management group. This means that some women will follow standard guidelines for managing their blood sugar, while others will have stricter goals to aim for. Throughout the study, participants will receive care and guidance from the research team to help manage their condition. It’s important to note that women who have certain health issues or complications during pregnancy, such as severe kidney disease or significant fetal anomalies, will not be eligible to participate. This research aims to improve outcomes for both mothers and their babies by finding the best ways to manage gestational diabetes.

Gender

FEMALE

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