Clinical trial
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
Recruiting now · Not applicable · 1 countries · Registry ID NCT05124808
Recruiting nowNot applicableInterventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 45 Years
SexFemale
Healthy volunteersNot accepted
ConditionGestational Diabetes, Pregnancy, High Risk, Overweight and Obesity
Full registry 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
Treatments and study arms
Intensive glycemic targets
Other
Fasting blood glucose \<90 mg/dL, 1 hour post-prandial blood glucose \<120 mg/dL
Standard glycemic targets
Other
Fasting blood glucose \<95 mg/dL, 1 hour post-prandial blood glucose \<140 mg/dL
Primary outcomes
Number of participants with composite neonatal morbidityWithin 7 days of delivery
Composite of large for gestational age birth weight, neonatal hypoglycemia, neonatal jaundice, and neonatal respiratory distress syndrome
Study locations
5 locations were listed when this page was built. The first 40 are shown.
University of Alabama at Birmingham🇺🇸 Birmingham, Alabama, United States
Ashley Battarbee, MD, MSCRContact
Ashley Battarbee, MD, MSCRPrincipal Investigator
Indiana University🇺🇸 Indianapolis, Indiana, United States
Christina Scifres, MDContact
Sarah Oswalt, RN, BSNContact
Christina Scifres, MDPrincipal Investigator
University of Oklahoma🇺🇸 Norman, Oklahoma, United States
Stephanie Pierce, MDContact
Stephanie Pierce, MDPrincipal Investigator
University of Pittsburgh🇺🇸 Pittsburgh, Pennsylvania, United States
Maisa Feghali, MDContact
Maisa Feghali, MDPrincipal Investigator