Clinical trial NCT02530866: Intensive Management for Gestational Diabetes
Official title: Randomized Controlled Clinical Pilot Trial of Intensive Management for Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in baseline maternal glycemia at 32-36 weeks gestation
timeFrame: 5 days at 2 separate times (1st study visit at 12-32 weeks, 2nd study visit at 32-36 weeks)
Secondary outcomes:
measure: Neonatal body composition
timeFrame: At birth
measure: Cytokine measurements
timeFrame: 20-30 weeks of gestation and 32-36 weeks of gestation
measure: Physical activity
timeFrame: 9 months
measure: Sleep assessments
timeFrame: 9 months
measure: Patient questionnaires
timeFrame: 9 months
measure: Lipid measurements
timeFrame: 20-30 weeks of gestation and 32-36 weeks of gestation
measure: Glucose measurements
timeFrame: 20-30 weeks of gestation and 32-36 weeks of gestation
measure: Lipid profile measurements
timeFrame: 20-30 weeks of gestation and 32-36 weeks of gestation
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Stephanie Pierce, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scifres CM, Mead-Harvey C, Nadeau H, Reid S, Pierce S, Feghali M, Myers D, Fields D, Stoner JA. Intensive glycemic control in gestational diabetes mellitus: a randomized controlled clinical feasibility trial. Am J Obstet Gynecol MFM. 2019 Nov;1(4):100050. doi: 10.1016/j.ajogmf.2019.100050. Epub 2019 Sep 27.