Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis

January 4, 2022 updated by: Ana L. Creo, Mayo Clinic

Oral Glucose Tolerance Testing Using Candy: A Sweet Solution to Improve Screening Compliance in Cystic Fibrosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
All 10 participants will go through the experimental arm receiving the dextrose candy oral glucose tolerance test.
Diagnostic test: Candy Glucose Tolerance Test
Participants will use a popular dextrose candy alternative to help assess glycemic response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic Response
Time Frame: Baseline, Day 1
The investigators will obtain glucose values at standard clinical times for oral glucose tolerance testing
Baseline, Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and Parent Satisfaction
Time Frame: Day 2
Self-rated satisfaction using the candy alternative will be assessed via survey
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

October 4, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-002446

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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