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Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
This study has been completed.
Sponsor:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Brian Casey, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00744965
First received: August 29, 2008
Last updated: January 25, 2017
Last verified: January 2017
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Purpose
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 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.
| Condition | Intervention | Phase |
|---|---|---|
| Mild Gestational Diabetes | Drug: Glyburide Drug: Placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo |
Resource links provided by NLM:
Further study details as provided by Brian Casey, University of Texas Southwestern Medical Center:
Primary Outcome Measures:
- Fetal weight reduction of 200gm with Glyburide treatment [ Time Frame: Immediately after delivery of fetus ]
Secondary Outcome Measures:
- Large for gestational age infants [ Time Frame: After delivery ]
- Macrosomia [ Time Frame: After delivery ]
- Neonatal Intensive Care Unit admissions [ Time Frame: Until hospital discharge ]
- Rate of cesarean delivery [ Time Frame: After delivery ]
- Risk of preeclampsia [ Time Frame: until hospital discharge ]
- Time to achieve glycemic control [ Time Frame: after delivery ]
- Need for insulin treatment [ Time Frame: after delivery ]
| Enrollment: | 395 |
| Study Start Date: | August 2008 |
| Study Completion Date: | January 2016 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Women with mild gestational diabetes will be started ADA diet and a low dose of Glyburide and their medication dosage will be titrated as necessary during the pregnancy to achieve glucose control.
|
Drug: Glyburide
Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.
|
|
Placebo Comparator: 2
Women with mild gestational diabetes will be started ADA diet and placebo.
|
Drug: Placebo
Sham dose adjustments of the placebo will be made.
|
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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 (<140mg/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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00744965
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744965
Locations
| United States, Texas | |
| Parkland Memorial Hospital | |
| Dallas, Texas, United States, 75235 | |
Sponsors and Collaborators
University of Texas Southwestern Medical Center
More Information
Publications:
| Responsible Party: | Brian Casey, Professor, University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00744965 History of Changes |
| Obsolete Identifiers: | NCT00942552 |
| Other Study ID Numbers: |
032011-086 042008-058 ( Other Identifier: UTexasSouthwestern ) |
| Study First Received: | August 29, 2008 |
| Last Updated: | January 25, 2017 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes, Gestational Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pregnancy Complications Glyburide Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 21, 2017