Oral Glucose Tolerance Testing Using Candy for Cystic Fib... | NCT04579939

Studies
Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis

NCT04579939

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jan 20, 2022Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Cystic Fibrosis

Interventions

Candy Glucose Tolerance Test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2021Actual

Primary Completion Date

Dec 30, 2021Actual

Completion Date

Dec 30, 2021Actual

First Submitted Date

Sep 29, 2020

First Submission Date that Met QC Criteria

Oct 4, 2020

First Posted Date

Oct 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2022

Last Update Posted Date

Jan 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Candy Glucose Tolerance Test	Diagnostic Test	Participants will use a popular dextrose candy alternative to help assess glycemic response.	Experimental

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ana Creo, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided