Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04579939 |
Recruitment Status :
Recruiting
First Posted : October 8, 2020
Last Update Posted : February 26, 2021
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Condition or disease | Intervention/treatment | Phase |
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Cystic Fibrosis | Diagnostic Test: Candy Glucose Tolerance Test | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Oral Glucose Tolerance Testing Using Candy: A Sweet Solution to Improve Screening Compliance in Cystic Fibrosis |
Actual Study Start Date : | February 25, 2021 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | June 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Experimental
All 10 participants will go through the experimental arm receiving the dextrose candy oral glucose tolerance test.
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Diagnostic Test: Candy Glucose Tolerance Test
Participants will use a popular dextrose candy alternative to help assess glycemic response. |
- Glycemic Response [ Time Frame: Baseline, Day 1 ]The investigators will obtain glucose values at standard clinical times for oral glucose tolerance testing
- Patient and Parent Satisfaction [ Time Frame: Day 2 ]Self-rated satisfaction using the candy alternative will be assessed via survey

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Ages Eligible for Study: | 10 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579939
United States, Minnesota | |
Mayo Clinic in Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Ana Creo, MD 507-284-3300 creo.ana@mayo.edu |
Principal Investigator: | Ana Creo, MD | Mayo Clinic |
Responsible Party: | Ana L. Creo, Principal Investigator, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT04579939 |
Other Study ID Numbers: |
20-002446 |
First Posted: | October 8, 2020 Key Record Dates |
Last Update Posted: | February 26, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |