RecruitingNot ApplicableNCT05124808

Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

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

Sponsor

Indiana University

Enrollment

828 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Overweight and Obesity Gestational Diabetes Pregnancy, High Risk

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria4

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 Criteria6

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

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Interventions

OTHERIntensive glycemic targets

Fasting blood glucose \<90 mg/dL, 1 hour post-prandial blood glucose \<120 mg/dL

OTHERStandard glycemic targets

Fasting blood glucose \<95 mg/dL, 1 hour post-prandial blood glucose \<140 mg/dL

Locations(5)

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

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