Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes Mellitus: A Multicenter Randomized Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 45 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares standard blood sugar goals with stricter goals during pregnancy. It is for pregnant women who are overweight or obese and have gestational diabetes, a type of diabetes diagnosed during pregnancy.
This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Pregnant women ages 18 to 45.
- Pregnant with one baby.
- Between 12 weeks and 32 weeks, 6 days pregnant, with gestational diabetes diagnosed during that time.
- Diabetes diagnosed by a 50-gram, 1-hour glucose screening test result of at least 200 mg/dL, or at least two high results on a 100-gram glucose tolerance test using the study’s required cutoffs. These tests measure blood sugar.
- Overweight or obese at the first pregnancy care visit: a BMI of at least 25, or at least 23 for Asian Americans. BMI is a measure of weight compared with height.
Who can't join
- Unable or unwilling to give informed consent, which means agreeing to join after learning about the study.
- Unable to communicate with the study team, even with an interpreter.
- Plan to give birth at a hospital that is not part of the study.
- Known kidney disease with a starting creatinine level above 1.5 mg/dL. Creatinine is a blood test used to check kidney function.
- The baby has a major birth defect diagnosed before joining, such as serious problems with the belly wall, spine, heart, or chromosomes that may cause early birth or raise the risk of death after birth.
- Used steroid medicine by mouth, into a vein, or into a muscle within 7 days before joining.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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) Exclusion Criteria: * 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
Study sites (5)
AL
- University of Alabama at Birmingham · Birmingham, AL 35294Ashley Battarbee, MD, MSCR · Study contact · anbattarbee@uambc.eduAshley Battarbee, MD, MSCR · Principal investigatorMore trials in Birmingham
IN
- Indiana University · Indianapolis, IN 46202Christina Scifres, MD · Study contact · (317) 948-4103 · cmscifre@iu.eduRasika Sadolikar, MBBS, MPH · Study contact · (317) 278-8040 · rsadolik@iu.eduChristina Scifres, MD · Principal investigatorMore trials in Indianapolis
OK
- University of Oklahoma · Norman, OK 73019Stephanie Pierce, MD · Study contact · Stephanie-Pierce@ouhsc.eduStephanie Pierce, MD · Principal investigatorMore trials in Norman
PA
- University of Pittsburgh · Pittsburgh, PA 15260Maisa Feghali, MD · Study contact · feghalim@mwri.magee.eduMaisa Feghali, MD · Principal investigatorMore trials in Pittsburgh
RI
- Women and Infants Hospital of Rhode Island · Providence, RI 02905Methodius Tuuli, MD, MPH, MBA · Study contact · MTuuli@Wihri.orgMethodius Tuuli, MD, MPH, MBA · Principal investigatorMore trials in Providence