Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT05124808

Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

Led by Indiana University · Updated on 2025-08-06

828

Participants Needed

5

Research Sites

214 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

U

University of Pittsburgh

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women between the ages of 18-45
  • Singleton gestation
  • Gestational age between 12 0/7 and 32 6/7 weeks with gestational diabetes diagnosed by 50g 1-hour glucose challenge test ≥200 mg/dL or two or more abnormal values on 100g oral glucose tolerance test using Carpenter-Coustan Criteria
  • Overweight or obese body mass index at first prenatal visit (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans)
Not Eligible

You will not qualify if you...

  • Inability or unwillingness to provide informed consent
  • Inability to communicate with study team members despite interpreter
  • Planned delivery at a non-study affiliated hospital
  • Known kidney disease with baseline creatinine >1.5 mg/dL
  • Significant fetal anomalies diagnosed before enrollment (e.g., gastroschisis, spina bifida, complex congenital heart disease, serious karyotypic anomalies)
  • Oral or intravenous/intramuscular steroid use within 7 days of enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 5 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

3

University of Oklahoma

Norman, Oklahoma, United States, 73019

Actively Recruiting

4

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15260

Actively Recruiting

5

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States, 02905

Actively Recruiting

Loading map...

Research Team

S

Sarah Oswalt

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here