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Dietary Supplement
Strawberry Candy Twist Challenge for Gestational Diabetes
N/A
Recruiting
Led By Kjersti Aagaard, MD, PhD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pregnant 24 to 28 weeks gestation
Be between 18 and 65 years old
Must not have
Known Type II DM
Known Type I DM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 to 28 weeks gestation
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effectiveness of two methods for screening for gestational diabetes.
Who is the study for?
This trial is for pregnant individuals between 24 to 28 weeks of gestation, carrying one or more babies (up to triplets), and willing to participate. It's not for those on steroids, with known Type I or II Diabetes, or a previous high blood sugar level after a glucose challenge test.
What is being tested?
The study is testing if eating 10 Twizzlers can be as effective as drinking the standard glucola beverage in screening for gestational diabetes. Participants will be given either Twizzlers or glucola and their blood sugar levels will be compared.
What are the potential side effects?
Potential side effects may include discomfort from consuming sugary products like feeling overly full, bloating, nausea, and possibly an increase in blood sugar levels which could affect the pregnancy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 24 and 28 weeks pregnant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have Type 2 diabetes.
Select...
I have Type 1 diabetes.
Select...
I am currently taking corticosteroids in pill or injection form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 to 28 weeks gestation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 to 28 weeks gestation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The serum glucose levels will be measured in response to oral glucose challenge and compared between Twizzlers and glucola beverage.
Secondary study objectives
Cost-effectiveness
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Twizzlers challengeExperimental Treatment1 Intervention
At a later date, the same prospective cohort of 617 women Participants will receive their Twizzlers challenge between 24 and 28 weeks gestational age.
Group II: Standard Glucola GCTActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,029,545 Total Patients Enrolled
Kjersti Aagaard, MD, PhD4.712 ReviewsPrincipal Investigator - Baylor College of Medicine
Baylor College of Medicine
5Patient Review
They were lovely! So kind and spent so much time with us.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 24 and 28 weeks pregnant.Your blood sugar level is higher than 190 mg/dl after drinking a 50 gram glucola beverage.I have Type 2 diabetes.I am willing to participate in the study.I have Type 1 diabetes.I am currently taking corticosteroids in pill or injection form.
Research Study Groups:
This trial has the following groups:- Group 1: Twizzlers challenge
- Group 2: Standard Glucola GCT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.