Treatment of Mild Gestational Diabetes With Glyburide Compared to Placebo
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies, Diabetes |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 16 - 45 |
| Updated: | 3/16/2015 |
| Start Date: | September 2008 |
| Contact: | Mina Abbassi-Ghanavati, MD |
| Email: | mina.abbassi-ghanavati@utsouthwestern.edu |
| Phone: | 214-648-2646 |
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
This is a randomized prospective trial which addresses the question of whether use of an
oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational
diabetes will result in achieving euglycemia in a shorter period of time and, in turn,
result in less frequent maternal and neonatal morbidities. This study is designed to test
the hypothesis that in women with mild gestational diabetes mellitus (GDM), use of Glyburide
in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams
as compared with diet and nutritional counseling alone.
oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational
diabetes will result in achieving euglycemia in a shorter period of time and, in turn,
result in less frequent maternal and neonatal morbidities. This study is designed to test
the hypothesis that in women with mild gestational diabetes mellitus (GDM), use of Glyburide
in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams
as compared with diet and nutritional counseling alone.
Inclusion Criteria:
- A glucose value of ≥ 140 mg/dl on a 50-gram oral glucose loading test by plasma at
gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical
information.
- An abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤ 105 mg/dl.
- Gestational age of less than or equal to 28 weeks and 0 days at the time of
consent/randomization.
- Singleton gestation.
Exclusion Criteria:
- Established pregestational diabetes.
- Abnormal gestational diabetes testing (≥ 140) prior to 24 weeks 0 days of gestation.
Women who have a negative glucose loading test (< 140 mg/dl) before 24 weeks may
still be considered for this study if they present again for glucose tolerance
testing between 24 and 27 weeks.
- Multiple gestations.
- Known major fetal anomaly or fetal demise.
- Any renal disease with serum creatinine of > 1.0.
- Known liver disease such as hepatitis.
- Maternal or fetal conditions likely to require imminent or very preterm delivery such
as preeclampsia, preterm premature rupture of the membranes, preterm labor, and
intrauterine fetal growth restriction.
- Known hypersensitivity or allergic reaction to Glyburide.
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