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Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT04579939
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
Ana L. Creo, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Diagnostic Test: Candy Glucose Tolerance Test Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Dextrose

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Glycemic Response [ Time Frame: Baseline, Day 1 ]
    The investigators will obtain glucose values at standard clinical times for oral glucose tolerance testing


Secondary Outcome Measures :
  1. Patient and Parent Satisfaction [ Time Frame: Day 2 ]
    Self-rated satisfaction using the candy alternative will be assessed via survey


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Ana Creo, MD    507-284-3300    creo.ana@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Ana Creo, MD Mayo Clinic
More Information
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Additional Information:

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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

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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
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases