NCT04579939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

10 months

First QC Date

September 29, 2020

Last Update Submit

January 4, 2022

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Glycemic Response

    The investigators will obtain glucose values at standard clinical times for oral glucose tolerance testing

    Baseline, Day 1

Secondary Outcomes (1)

  • Patient and Parent Satisfaction

    Day 2

Study Arms (1)

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

Candy Glucose Tolerance TestDIAGNOSTIC_TEST

Participants will use a popular dextrose candy alternative to help assess glycemic response.

Experimental

Eligibility Criteria

Age10 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Ana Creo, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 8, 2020

Study Start

February 25, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)