Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
Recruiting now · Not applicable
Conditions studied: Gestational Diabetes, Pregnancy, High Risk, Overweight and Obesity
In brief
This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.
Key facts
- Study ID
- NCT05124808
- Run by
- Indiana University
- People needed
- 828
- Starts
- 2022-03-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-06-24
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- Indiana University — Indianapolis, Indiana, United States (enrolling)
- University of Oklahoma — Norman, Oklahoma, United States (enrolling)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
- Women and Infants Hospital of Rhode Island — Providence, Rhode Island, United States (enrolling)
Full record on ClinicalTrials.gov
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