Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

Description

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

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Study Overview

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Study Details

Study overview

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

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

Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

Condition
Gestational Diabetes
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Norman

University of Oklahoma, Norman, Oklahoma, United States, 73019

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15260

Providence

Women and Infants Hospital of Rhode Island, Providence, Rhode Island, United States, 02905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Christina Scifres, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

2026-04-08