Treatment of Mild Gestational Diabetes With Glyburide Compared to Placebo

Condition(s) targeted: Gestational Diabetes; Pregnancy Complications

Intervention: Glyburide (Drug); Placebo (Drug); ADA diet + nutritional counseling (Behavioral)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Texas Southwestern Medical Center

Official(s) and/or principal investigator(s):
Mina Abbassi-Ghanavati, MD, Principal Investigator, Affiliation: UT Southwestern Medical Center

Overall contact:
Mina Abbassi-Ghanavati, MD, Phone: 214-648-2646, Email: mina.abbassi-ghanavati@utsouthwestern.edu

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.

Official title: Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Primary outcome: Fetal weight reduction of 200 gm

Secondary outcome:

Large for gestational age infants

Macrosomia

Neonatal Intensive Care Unit admissions

Risk of preeclampsia

Rate of cesarean delivery

Time to achieve glycemic control

Need for insulin treatment

Minimum age: 16 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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.

Mina Abbassi-Ghanavati, MD, Phone: 214-648-2646, Email: mina.abbassi-ghanavati@utsouthwestern.edu

Parkland Memorial Hospital, Dallas, Texas 75235, United States; Recruiting
Mina Abbassi-Ghanavati, MD, Principal Investigator

Starting date: September 2008
Last updated: July 19, 2009