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Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

NCT05124808 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 828

Last updated 2025-08-06

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes
  • Pregnancy, High Risk
  • Overweight and Obesity

Interventions

OTHER

Intensive glycemic targets

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

OTHER

Standard glycemic targets

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

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • University of Oklahoma

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Women and Infants Hospital of Rhode Island

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Christina Scifres, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2026-04-01
Completion
2026-04-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05124808 on ClinicalTrials.gov