Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Indiana University
Study ID
NCT05124808
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Mar 1, 2022
Status verified
Aug 2025
Primary completion
Apr 1, 2026
Completion
Apr 8, 2026

Study Design

Enrollment
828 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intensive glycemic targets
    Participants in this arm will target a fasting blood glucose of \<90 mg/dL and 1 hour post-prandial blood glucose values \<120 mg/dL.
  • Active Comparator: Standard glycemic targets
    Participants in this arm will target a fasting blood glucose of \<95 mg/dL and 1 hour post-prandial blood glucose values \<140 mg/dL.

Primary Outcome Measure

Number of participants with composite neonatal morbidity [ Time Frame: Within 7 days of delivery ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Ashley Battarbee, MD, MSCR
[email protected]
Ashley Battarbee, MD, MSCR (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Christina Scifres, MD
[email protected]
317-948-4103
Sarah Oswalt, RN, BSN
[email protected]
(317) 944-7069
Christina Scifres, MD (PRINCIPAL_INVESTIGATOR)
University of OklahomaNormanOklahoma73019
Stephanie Pierce, MD
[email protected]
Stephanie Pierce, MD (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15260
Maisa Feghali, MD
[email protected]
Maisa Feghali, MD (PRINCIPAL_INVESTIGATOR)
Women and Infants Hospital of Rhode IslandProvidenceRhode Island02905
Methodius Tuuli, MD, MPH, MBA
[email protected]
Methodius Tuuli, MD, MPH, MBA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Alabama at Birmingham· Birmingham, ALIndiana University· Indianapolis, INUniversity of Oklahoma· Norman, OKUniversity of Pittsburgh· Pittsburgh, PAWomen and Infants Hospital of Rhode Island· Providence, RI

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