The Effects of the CF Carrier State on the Kidneys and Pancreas
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorPhilip Polgreen
About this trial
The overarching hypothesis is that CF carriers are at increased risk for developing most of the extrapulmonary conditions associated with CF compared to the general population. Specifically, it is hypothesized that this pilot data will detect subclinical evidence of pancreatic and kidney disorders among CF carriers. This will be determined by bringing CF carriers and controls to the CRU for one visit where they will answer survey questions and undergo laboratory testing. Additionally, they will collect urine and stool samples at home that will be sent to outside laboratories for testing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A CF Carrier identified via genetic testing
No previous CF carrier test results
Disqualifiers
CF patient status
Unable to speak English
Currently pregnant
Unable to provide written informed consent
Trial population
CF Carriers and Controls who are not CF carriers.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
1,250 Participants
are grouped into 2 trial groupsGroup A: Cystic Fibrosis Carrier Group
Group B: Control Group
Trial outcomes
Primary outcomes
1
Comparison of Glucose Values
Comparison of glucose values in cystic fibrosis carrier group vs control group via t-tests.
Time frame
At baseline2
Comparison of Insulin Values
Comparison of insulin values in cystic fibrosis carrier group vs control group via t-tests.
Time frame
At baselineSecondary outcomes
1
Comparison of C-Reactive Protein Values
Comparison of c-reactive protein values in cystic fibrosis carrier group vs control group via t-tests.
Time frame
At baseline2
Comparison of Lactoferrin Values
Comparison of lactoferrin values in cystic fibrosis carrier group vs control group via t-tests.
Time frame
At baseline3
Comparison of Calprotectin Values
Comparison of calprotectin values in cystic fibrosis carrier group vs control group via t-tests.
Time frame
At baseline4
Comparison of Lipid Values
Comparison of lipid values in cystic fibrosis carrier group vs control group via t-tests.
Time frame
At baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Philip Polgreen
Lead sponsor
University of Iowa
Sponsor institution
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov