Recruiting

Observational Study

Sponsor:

Philip Polgreen

Code:

NCT05474417

Conditions

Carrier State

Pancreatic Disease

Kidney Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Carrier State

Pancreatic Disease

Kidney Diseases

Study ID

NCT05474417

Start date

Dec 20, 2021

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

CF Carrier Inclusion Criteria:

  • A CF Carrier identified via genetic testing

Control Inclusion Criteria:

  • No previous CF carrier test results

Exclusion Criteria:

  • CF patient status
  • Unable to speak English
  • Currently pregnant
  • Unable to provide written informed consent
  • Prisoner status
  • Currently taking any medications for the treatment of diabetes

Study Design

Enrollment

1250 participants

Anticipated

Interventions and Outcome Measures

Arms

Cystic Fibrosis Carrier Group

Participants who have been identified as Cystic Fibrosis Carriers via previous genetic testing.

Control Group

Participants who have been identified as not being Cystic Fibrosis Carriers via previous genetic testing.

Primary outcome measure

  • Comparison of Glucose Values [ Time Frame: At baseline ]
  • Comparison of Insulin Values [ Time Frame: At baseline ]

Central Contacts and Locations

Central contacts

Philip M Polgreen, MD

(319) 384-6194philip-polgreen@uiowa.edu

Shelby L Francis, PhD

319-678-8037shelby-francis@uiowa.edu

Locations

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Shelby L Francis, PhD

319-678-8037shelby-francis@uiowa.edu

More Information

Sponsor

Philip Polgreen

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Philip Polgreen on 2026-09-04.