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Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

Recruiting

Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes Mellitus: A Multicenter Randomized Trial

Who can join

Ages 18 to 45 · Women

Full 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

About the study

This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.

What is being tested

Sponsor: Indiana University · Participants: 828 · Started: Mar 1, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05124808

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham, Birmingham
IndianaIndiana University, Indianapolis
OklahomaUniversity of Oklahoma, Norman
PennsylvaniaUniversity of Pittsburgh, Pittsburgh
Rhode IslandWomen and Infants Hospital of Rhode Island, Providence

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.