Intensive glycaemic targets in overweight and obese individuals with gestational diabetes mellitus: clinical trial protocol for the iGDM study.
Christina M Scifres, Ashley N Battarbee, Maisa N Feghali...
https://pubmed.ncbi.nlm.nih.gov/38423770Actively Recruiting
Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID05124808
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes Mellitus: A Multicenter Randomized Trial
Led by Indiana University · Updated on 2025-08-06
828
Participants Needed
5
Research Sites
1 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
Researchers are evaluating the impact of intensive versus standard blood sugar targets in overweight and obese pregnant women diagnosed with gestational diabetes. This study aims to compare how these treatment approaches affect the health of newborns and mothers. The trial involves 828 women across multiple centers in the U.S., focusing on improving outcomes like reducing complications related to high blood sugar during pregnancy. Participants are randomly assigned to one of two groups: one aiming for intensive blood sugar control with fasting glucose less than 90 mg/dL and one-hour post-meal glucose less than 120 mg/dL, and the other following standard targets of fasting glucose less than 95 mg/dL and one-hour post-meal glucose less than 140 mg/dL. These target levels are monitored throughout the pregnancy until delivery. Women in the study undergo regular monitoring of blood sugar levels, with assessments of both maternal and newborn health outcomes including neonatal complications, birth weight, and maternal hypoglycemia. Researchers will also evaluate the safety of the intensive targets and the cost-effectiveness of the treatments. The main outcome measured is the number of newborns experiencing a combination of health issues within the first week after birth. The study is expected to last over several years, with participants involved from diagnosis until delivery.
CONDITIONS
Brief Title
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
Who Can Participate
Age: 18Years - 45Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Pregnant women between the ages of 18-45
- Singleton pregnancy (one baby)
- Gestational age between 12 0/7 and 32 6/7 weeks with gestational diabetes diagnosed during this time using specific glucose tests
- Overweight or obese at first prenatal visit (BMI 65 kg/m2 or 63 kg/m2 for Asian Americans)
You will not qualify if you...
- Unable or unwilling to give informed consent
- Unable to communicate with the study team even with an interpreter
- Plan to deliver at a hospital not affiliated with the study
- Known kidney disease with creatinine over 1.5 mg/dL
- Significant fetal anomalies diagnosed before joining the study
- Use of oral or intravenous/intramuscular steroids within 7 days before joining the study
AI-Screening
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1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From randomization until delivery
Participants receive intensive or standard glycemic targets to manage blood glucose levels during pregnancy.
Regular visits as part of prenatal care (frequency varies)
Follow-up
Duration - Up to 30 days after delivery
Participants and their infants are monitored for perinatal outcomes and safety up to 30 days after delivery.
Approximately 1 to 2 visits after delivery
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
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Research Team
S
Sarah Oswalt
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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