Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensive glycemic targets, Standard glycemic targets.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes, Pregnancy, High Risk, Overweight and Obesity. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes Mellitus: A Multicenter Randomized Trial
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.
Detailed description
The prevalence of both obesity and gestational diabetes mellitus (GDM) have increased, and each is associated with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of pregnancy, and cesarean delivery. Women with GDM who are also overweight and obese have higher rates of pregnancy complications when compared to normal weight women with GDM, which may occur in part due to suboptimal glycemic control. The current recommendations for glycemic targets in pregnant women with diabetes are not rigorously defined, and they far exceed the mean fasting (70.9 ±7.8 mg/dL) and 1 hour post- prandial (108.9 ± 12.9 mg/dL) glucose values in pregnant women without GDM. Our prior work demonstrated that use of intensive (fasting \<90, 1 hr post-prandial \<120 mg/dL) compared to standard (fasting \<95 mg/dL, 1 hr post-prandial \<140 mg/dL) glycemic targets resulted in improved glycemic control without increasing the risk for hypoglycemia. The Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial (iGDM Trial) is a large, pragmatic randomized clinical trial designed to investigate the impact of intensive versus standard glycemic targets on perinatal outcomes in women with GDM who are overweight and obese. During the 5-year project period, a multidisciplinary team of investigators from 4 medical centers representing regions of the U.S. with high rates of obesity will randomize 828 overweight and obese women with GDM to either intensive or standard glycemic targets. The specific aims of this project are: 1) Determine the effectiveness of intensive glycemic targets in reducing the risk for neonatal composite morbidity and large for gestational age birthweight in overweight and obese women with GDM, 2) Assess the safety of intensive glycemic targets as measured by the frequency of maternal hypoglycemia in overweight and obese women with GDM, and 3) Evaluate the cost-effectiveness of intensive glycemic control compared with standard glycemic control as measured by the incremental cost per case of neonatal morbidity and LGA birth weight prevented and per Quality-adjusted Life-year. The expected outcome of this study is high-quality evidence on the effectiveness, safety, and cost-effectiveness of intensive glycemic targets in reducing adverse perinatal outcomes among overweight and obese women with GDM. If proven effective, use of intensive glycemic targets in overweight and obese women with GDM will have an important positive impact on the health of these high risk women and their infants.
Interventions
- Other Intensive glycemic targets
Fasting blood glucose \<90 mg/dL, 1 hour post-prandial blood glucose \<120 mg/dL - Other Standard glycemic targets
Fasting blood glucose \<95 mg/dL, 1 hour post-prandial blood glucose \<140 mg/dL
Primary outcome measures
- Number of participants with composite neonatal morbidity [Time frame: Within 7 days of delivery]
Secondary outcome measures (12)
- Number of participants with large for gestational age birth weight [Time frame: Birth]
- Number of participants with neonatal hypoglycemia [Time frame: Within 24 hours of delivery]
- Number of participants with neonatal jaundice [Time frame: Within 7 days of delivery]
- Number of participants with respiratory distress syndrome [Time frame: Within 7 days of delivery]
- Maternal hyperglycemia [Time frame: From randomization to delivery]
- Early maternal glycemic levels [Time frame: 7 days after randomization]
- Pre-delivery maternal glycemic levels [Time frame: 14 days prior to delivery]
- Glycemic levels during study enrollment [Time frame: Up to 29 weeks]
- Episodes of maternal hypoglycemia [Time frame: From randomization to delivery]
- Number of episodes of symptomatic maternal hypoglycemia [Time frame: From randomization to delivery]
- Number of participants with hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia) [Time frame: From randomization up to 30 days after delivery]
- Number of participants with small for gestational age birth weight [Time frame: Birth]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- University of Alabama at Birmingham — Birmingham
- Indiana University — Indianapolis
- University of Oklahoma — Norman
- University of Pittsburgh — Pittsburgh
- Women and Infants Hospital of Rhode Island — Providence
Publications
- Scifres CM, Battarbee AN, Feghali MN, Pierce S, Edwards RK, Smith EM, Guise D, Bhamidipalli S, Daggy J, Tuuli MG. Intensive glycaemic targets in overweight and obese individuals with gestational diabetes mellitus: clinical trial protocol for the iGDM study. BMJ Open. 2024 Feb 29;14(2):e082126. doi: 10.1136/bmjopen-2023-082126. PMID 38423770
Identifiers
NCT: NCT05124808 · 11435 · R01HD101476