Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorIndiana University
About this trial
This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Intensive glycemic targets
- Standard glycemic targets
Treatment groups
828 Participants
are divided into 2 treatment groupsLocations
5University of Alabama at Birmingham35294, BirminghamAlabama, United States
Indiana University46202, IndianapolisIndiana, United States
University of Oklahoma73019, NormanOklahoma, United States
University of Pittsburgh15260, PittsburghPennsylvania, United States
Sponsors and collaborators
Indiana University
Lead sponsor
University of Pittsburgh
Collaborator
University of Alabama at Birmingham
Collaborator
University of Oklahoma
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Women and Infants Hospital of Rhode Island
Collaborator
Source ClinicalTrials.gov