Back to resultsOral Glucose Tolerance Testing Using Candy for Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Candy Glucose Tolerance Test
Sponsored by
About this trial
This is an interventional basic science trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Males and Females ages 10-21 years.
- Cystic Fibrosis (CF) must be diagnosed.
- Ability to sign informed consent if they are 18 years or older.
- Written parental permission if age 10-17 years old.
Exclusion criteria:
- Active CF flare as determined by the primary CF team .
- Use of steroids.
- Inability to tolerate oral feedings.
- Prior intestinal surgery.
- Concern for allergy or intolerance to dextrose, fructose, or corn derivatives.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
All 10 participants will go through the experimental arm receiving the dextrose candy oral glucose tolerance test.
Outcomes
Primary Outcome Measures
Glycemic Response
The investigators will obtain glucose values at standard clinical times for oral glucose tolerance testing
Secondary Outcome Measures
Patient and Parent Satisfaction
Self-rated satisfaction using the candy alternative will be assessed via survey
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04579939
Brief Title
Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis
Official Title
Oral Glucose Tolerance Testing Using Candy: A Sweet Solution to Improve Screening Compliance in Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to determine if a popular dextrose candy alternative yields a similar glycemic curve compared to the standard oral Dextrose solution used in the Oral Glucose Tolerance Test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
All 10 participants will go through the experimental arm receiving the dextrose candy oral glucose tolerance test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Candy Glucose Tolerance Test
Intervention Description
Participants will use a popular dextrose candy alternative to help assess glycemic response.
Primary Outcome Measure Information:
Title
Glycemic Response
Description
The investigators will obtain glucose values at standard clinical times for oral glucose tolerance testing
Time Frame
Baseline, Day 1
Secondary Outcome Measure Information:
Title
Patient and Parent Satisfaction
Description
Self-rated satisfaction using the candy alternative will be assessed via survey
Time Frame
Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and Females ages 10-21 years.
Cystic Fibrosis (CF) must be diagnosed.
Ability to sign informed consent if they are 18 years or older.
Written parental permission if age 10-17 years old.
Exclusion criteria:
Active CF flare as determined by the primary CF team .
Use of steroids.
Inability to tolerate oral feedings.
Prior intestinal surgery.
Concern for allergy or intolerance to dextrose, fructose, or corn derivatives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Creo, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis
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