Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial
Part of paid clinical trials in Houston, Texas.
- Sponsor
- Baylor College of Medicine
- Study ID
- NCT02610179
- Status
- Recruiting
Conditions
- Gestational Diabetes Mellitus
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 64 Years
- Healthy Volunteers
- Accepted
Interventions
- Standard Glucola GCT — DIETARY_SUPPLEMENTParticipants will be screened with the standard method of consumption of the glucola beverage followed by a 1 hour venous blood draw.
- Twizzlers challenge — DIETARY_SUPPLEMENTParticipants will consume the Twizzlers equivalent (10 strawberry flavored Twizzlers) and have their venous blood glucose checked in 1 hour.
Study Details
The goal of this prospective study is to determine whether there is superiority of 10 Twizzlers to the 50 gram glucola beverage for screening for GDM in a population based study.
Key Dates
- Start date
- Apr 30, 2015
- Status verified
- May 2023
- Primary completion
- Jan 31, 2025
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 617 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SCREENING
Arms
- Active Comparator: Standard Glucola GCTA prospective cohort of 617 women who will undergo screening for gestational diabetes with the standard glucola GCT between 24 and 28 weeks gestational age.
- Experimental: Twizzlers challengeAt a later date, the same prospective cohort of 617 women Participants will receive their Twizzlers challenge between 24 and 28 weeks gestational age.
Primary Outcome Measure
The serum glucose levels will be measured in response to oral glucose challenge and compared between Twizzlers and glucola beverage. [ Time Frame: 24 to 28 weeks gestation ]
Central Contacts
- Kjersti Aagaard, MD, PhD713-798-8467
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ben Taub General Hospital | Houston | Texas | 77030 |
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