Hormonal Responses to a Mixed Meal in People With Cystic Fibrosis
ConditionCystic Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorUniversity of Cincinnati
About this trial
In this exploratory study, the hormonal responses to a mixed meal will be examined in people with cystic fibrosis. The aim of this study is to find correlates with impaired glucose tolerance that is associated with this population.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosed with cystic fibrosis
Aged 18 to 45 years
Males and females of any race and ethnicity
Receiving highly effective CFTR modular therapy
Disqualifiers
Transplant recipient
Acute lung function decline or exacerbation within the last 3 months
Use of systemic glucocorticoids
Pregnancy
Trial population
Healthy controls and people with cystic fibrosis will be examined.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Mixed meal
Other interventionEach individual will ingest 5 mL/kg of Boost energy drink.
Treatment groups
61 Participants
are divided into 4 treatment groupsGroup A: Healthy controls1 intervention
Group B: Pancreatic sufficient CF1 intervention
Group C: Pancreatic insufficient CF1 intervention
Group D: CF-related diabetes1 intervention
Trial outcomes
Primary outcomes
1
Concentration of Insulin
human plasma
Time frame
Up to 3 hours2
Concentration of Glucagon
human plasma
Time frame
Up to 3 hours3
Concentration of Somatostatin
human plasma
Time frame
Up to 3 hours4
Concentration of Glucose
human plasma
Time frame
Up to 3 hoursSecondary outcomes
1
Concentration of GLP-1
human plasma
Time frame
Up to 3 hours2
Concentration of GIP
human plasma
Time frame
Up to 3 hours3
Concentration of fatty acids
human plasma
Time frame
Up to 3 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Cincinnati
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov