NCT05124808 Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
| NCT ID | NCT05124808 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Gestational Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 828 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 828 participants in total. It began in 2022-03-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Christina Scifres, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT05124808 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Gestational Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05124808 currently recruiting?
Yes, NCT05124808 is actively recruiting participants. Contact the research team at seoswalt@iu.edu for enrollment information.
Where is the NCT05124808 trial being conducted?
This trial is being conducted at Birmingham, United States, Indianapolis, United States, Norman, United States, Pittsburgh, United States and 1 additional location.
Who is sponsoring the NCT05124808 clinical trial?
NCT05124808 is sponsored by Indiana University. The principal investigator is Christina Scifres, MD at Indiana University. The trial plans to enroll 828 participants.
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