RECRUITING

Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

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Conditions

Gestational DiabetesPregnancy, High RiskOverweight and Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-03-01
Study Completion:2026-04-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05124808

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.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant women between the ages of 18-45
  2. * Singleton gestation
  3. * 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
  4. * Overweight or obese BMI at the first prenatal visit (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans)
  1. * Inability or unwillingness to provide informed consent
  2. * Inability to communicate with members of the study team, despite the presence of an interpreter
  3. * Planned delivery at a non-study affiliated hospital
  4. * Known renal disease with a baseline creatinine \>1.5 mg/dL
  5. * 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)
  6. * Oral or IV/IM steroid use within 7 days of study enrollment

Contacts and Locations

Study Contact

Sarah Oswalt
CONTACT
(317)944-7069
seoswalt@iu.edu

Principal Investigator

Christina Scifres, MD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Indiana University
Indianapolis, Indiana, 46202
United States
University of Oklahoma
Norman, Oklahoma, 73019
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Christina Scifres, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-01
Study Completion Date2026-04-08

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2026-04-08

Terms related to this study

Additional Relevant MeSH Terms

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