Intensive Management for Gestational Diabetes
Status: | Active, not recruiting |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 3/3/2019 |
Start Date: | November 2015 |
End Date: | January 2020 |
Randomized Controlled Clinical Pilot Trial of Intensive Management for Gestational Diabetes
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.
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.
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.
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.
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.
We found this trial at
1
site
940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
Phone: 405-271-8001
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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