Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
Recruiting · NCT05124808 · Interventional (participants receive a specific treatment) · Lead sponsor: Indiana University
View the official record on ClinicalTrials.gov →Interventions studied
Intensive glycemic targetsStandard glycemic targets
What this trial is about
This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
5 locations listed across 5 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Indiana University - Indianapolis, Indiana, United States
- University of Oklahoma - Norman, Oklahoma, United States
- University of Pittsburgh - Pittsburgh, Pennsylvania, United States
- Women and Infants Hospital of Rhode Island - Providence, Rhode Island, United States