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NCT04579939 Clinical Trial

Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04579939
Other study ID # 20-002446
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 25, 2021
Est. completion date December 30, 2021

Study information
Verified date January 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 10 Years to 21 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Candy Glucose Tolerance Test
Participants will use a popular dextrose candy alternative to help assess glycemic response.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glycemic Response The investigators will obtain glucose values at standard clinical times for oral glucose tolerance testing Baseline, Day 1
Secondary Patient and Parent Satisfaction Self-rated satisfaction using the candy alternative will be assessed via survey Day 2
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