Randomized Controlled Clinical Pilot Trial of Intensive Management for Gestational Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oklahoma
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in baseline maternal glycemia at 32-36 weeks gestation
Study Overview
Brief Summary
This is a randomized clinical pilot trial designed to assess the feasibility of randomizing obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration will also be compared between groups.
Detailed Description
The investigators will randomize 60 obese pregnant women with a new diagnosis of gestational diabetes using the Carpenter-Coustan criteria in a 1:1 fashion to either standard care or intensive therapy. Subjects will be randomized to either standard care or intensive therapy at the first study visit, which will occur between 12-32 weeks of gestation after they have completed their gestational diabetes testing. Neither patients nor their providers will be blinded to patient study group. All women will receive standard nutritional counseling at the time of diagnosis, and they will also be treated with either glyburide or insulin as dictated by standard care. Women will return for a second study visit between 32-36 weeks of gestation to assess the impact of their glycemic target groups on overall glycemic control. The investigators will also collect information on the type and dose of each medication required to maintain glycemic control in women randomized to either standard care or intensive therapy.
In addition to standard glucose monitoring 4x/day (fasting and one-hour post breakfast, lunch, and dinner), the investigators will utilize blinded continuous glucose monitors (iPro, Medtronic) at each study visit. Because women with GDM are receiving active management of their blood sugars and dietary counseling, the investigators will assess CGM for 5 consecutive days both at study enrollment and again between 32-36 weeks. Study participants will complete food diaries during their CGM monitoring to correlate food intake with glycemic variation. The investigators will also compare maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration between groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •maternal age between 18-45 years
- •singleton birth
- •planned delivery at OU Medical Center
- •GDM diagnosed between 12-32 weeks' gestation by either a 50 gram
- •one hour GCT >200 mg/dL or two or more abnormal values on a 100 gram OGTT using the Carpenter-Coustan criteria
- •pre-pregnancy BMI ≥26 kg/m2.
Exclusion Criteria
- •maternal tobacco use
- •planned delivery prior to 34 weeks of gestation
- •significant fetal anomalies
- •chronic hypertension requiring medication
- •other vascular disease
- •known renal disease with a baseline serum creatinine >1.5 mg/dL
- •maternal rheumatologic disorders requiring medication
- •maternal human immunodeficiency virus (HIV) or hepatitis
- •as the specimen storage facility is not accredited to handle such samples
- •steroid use within 7 days.
Arms & Interventions
Standard care
Women in this arm will target fasting blood glucose values <95 mg/dL and 1 hour post-prandial values <140 mg/dL
Intervention: Lower glycemic targets (Other)
Intensive therapy
Women in the arm will target fasting blood glucose values <90 mg/dL and 1 hour post-prandial values <120 mg/dL.
Intervention: Lower glycemic targets (Other)
Outcomes
Primary Outcomes
Change in baseline maternal glycemia at 32-36 weeks gestation
Time Frame: 5 days at 2 separate times (1st study visit at 12-32 weeks, 2nd study visit at 32-36 weeks)
Women will undergo CGM for 5 days at both the first study visit (12-32 weeks) and again at the second study visit (32-36 weeks). Our primary outcome between women randomized to either SC or IT will compare mean 24-hour blood glucose levels as assessed by continuous glucose monitor at the 2nd study visit, which will occur between 32-36 weeks of gestation. Investigators hypothesize that women randomized to the IT group will have a 10 mg/dL lower mean 24-hour glucose as assessed by continuous glucose monitor when compared to women in the SC group. Investigators will also assess the prevalence of maternal hypoglycemia by comparing the amount of time with maternal blood glucose values \<60 mg/dL between groups.
Secondary Outcomes
- Cytokine measurements(20-30 weeks of gestation and 32-36 weeks of gestation)
- Glucose measurements(20-30 weeks of gestation and 32-36 weeks of gestation)
- Lipid measurements(20-30 weeks of gestation and 32-36 weeks of gestation)
- Patient questionnaires(9 months)
- Physical activity(9 months)
- Neonatal body composition(At birth)
- Sleep assessments(9 months)
- Lipid profile measurements(20-30 weeks of gestation and 32-36 weeks of gestation)