Status:
COMPLETED
Optimizing Outcomes in Women With Gestational Diabetes Mellitus and Their Infants
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether a 14 week intervention is successful in improving outcomes for women with gestational diabetes mellitus and their infants.
Detailed Description
Women who are diagnosed with gestational diabetes are at increased risk for developing prediabetes and type 2 diabetes. To date, there have been few interdisciplinary interventions that target predomi...
Eligibility Criteria
Inclusion
- Women between 22-36 weeks of pregnancy who are diagnosed with GDM
- A diagnosis of GDM during the current pregnancy by two or more 100g Oral Glucose Tolerance Test (OGTT) values exceeding established thresholds (fasting 95, 1h 180, 2h 155, 3h 140 mg/dL)
- Age 18-45 years old
- A pre-pregnancy body mass index \> 25kg/m2
- Ability to read and write in English
- Willingness to consent for themselves and their infant
Exclusion
- They have a A1c ≥ 6.5 mg/dL (Type 2 diabetes)
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01809431
Start Date
May 1 2012
End Date
July 1 2014
Last Update
June 13 2024
Active Locations (2)
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1
UNC-Rex Health Care
Raleigh, North Carolina, United States, 27607
2
WakeMed
Raleigh, North Carolina, United States, 27610