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_SUPPLEMENT
    Participants will be screened with the standard method of consumption of the glucola beverage followed by a 1 hour venous blood draw.
  • Twizzlers challenge — DIETARY_SUPPLEMENT
    Participants 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 GCT
    A 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 challenge
    At 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

Locations (1)

FacilityCityStateZIPSite coordinators
Ben Taub General HospitalHoustonTexas77030
Kjersti Aagaard, MD, PhD
713-798-8467

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