Recruiting

Strawberry Candy Twists

Sponsor:

Baylor College of Medicine

Code:

NCT02610179

Conditions

Gestational Diabetes Mellitus

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Standard Glucola GCT

Twizzlers challenge

Study Details

Brief summary:

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.

Conditions

Gestational Diabetes Mellitus

Study ID

NCT02610179

Start date

Apr, 2015

Status verified date

May, 2023

Completion date

Mar, 2027

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pregnant
  • 24 to 28 weeks gestation
  • Singleton or twin or triplet gestation
  • Willing to participate in the study

Exclusion Criteria:

  • Known Type II DM
  • Known Type I DM
  • On oral or injectable corticosteroids
  • 50 gram glucola beverage GCT of greater than or equal to 190 mg/dl

Study Design

Enrollment

617 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

Standard Glucola GCT

Participants will be screened with the standard method of consumption of the glucola beverage followed by a 1 hour venous blood draw.

Twizzlers challenge

Participants will consume the Twizzlers equivalent (10 strawberry flavored Twizzlers) and have their venous blood glucose checked in 1 hour.

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 and Locations

Central contacts

Kjersti Aagaard, MD, PhD

713-798-8467aagaardt@bcm.edu

Locations

Ben Taub General Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Kjersti Aagaard, MD, PhD

713-798-8467aagaardt@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

May 11, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2023-05-11.