Cystic FibrosisNCT04579939
Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis
A study testing Candy Glucose Tolerance Test in people with Cystic Fibrosis, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Candy Glucose Tolerance Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Candy Glucose Tolerance Test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candy Glucose Tolerance TestDiagnostic test
Participants will use a popular dextrose candy alternative to help assess glycemic response.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All 10 participants will go through the experimental arm receiving the dextrose candy oral glucose tolerance test. Receives: Diagnostic Test: Candy Glucose Tolerance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Response
The investigators will obtain glucose values at standard clinical times for oral glucose tolerance testing
Measured: Baseline, Day 1
Secondary outcomes (1)
Patient and Parent Satisfaction
Self-rated satisfaction using the candy alternative will be assessed via survey
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start25 Feb 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana L. Creo, Mayo Clinic
- Investigators
- Ana Creo, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579939
- Sponsor's protocol ID
- 20-002446
- Status last verified
- Jan 2022
- First submitted
- 29 Sep 2020
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Glucose Tolerance Testing Using Candy: A Sweet Solution to Improve Screening Compliance in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04579939
- Acronym / sponsor ID
- 20-002446
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: Candy Glucose Tolerance TestAll 10 participants will go through the experimental arm receiving the dextrose candy oral glucose tolerance test. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candy Glucose Tolerance TestParticipants will use a popular dextrose candy alternative to help assess glycemic response. | Diagnostic test | Experimental |
Primary outcome
Glycemic Response
Time frame: Baseline, Day 1
The investigators will obtain glucose values at standard clinical times for oral glucose tolerance testing
1 secondary outcome
Patient and Parent Satisfaction
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Creo, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Candy Glucose Tolerance Test in people with Cystic Fibrosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Response (time frame: Baseline, Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.