Comparing glycemic targets in overweight and obese women with gestational diabetes
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes Mellitus: A Multicenter Randomized Trial
This study tests whether setting stricter blood sugar goals during pregnancy helps overweight and obese women with gestational diabetes have better outcomes for themselves and their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 828 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Indiana University Academic / other |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Trial ID | NCT05124808 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized clinical trial involves 828 overweight and obese pregnant women diagnosed with gestational diabetes. The study aims to compare the effects of intensive glycemic targets against standard glycemic targets on perinatal outcomes. Participants will be monitored throughout their pregnancy to assess the impact of these glycemic control strategies on complications associated with gestational diabetes. The trial is conducted across four medical centers in the U.S. with high obesity rates, ensuring a diverse participant pool.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18-45 with a singleton gestation and diagnosed with gestational diabetes while being overweight or obese.
Not a fit: Patients with significant fetal anomalies or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pregnancy outcomes for overweight and obese women with gestational diabetes.
How similar studies have performed: Previous studies have shown promising results with intensive glycemic control in similar populations, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 4 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- University of Oklahoma — Norman, Oklahoma, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Women and Infants Hospital of Rhode Island — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Christina Scifres, MD — Indiana University
- Study coordinator: Sarah Oswalt
- Email: seoswalt@iu.edu
- Phone: (317)944-7069
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.