The Effects of the CF Carrier State on the Kidneys and Pancreas

NCT05474417 | Recruiting

• 2 other identifiers: 2020124475P30DK054759
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Comparison of Glucose Values

  Comparison of glucose values in cystic fibrosis carrier group vs control group via t-tests.

  At baseline

• Comparison of Insulin Values

  Comparison of insulin values in cystic fibrosis carrier group vs control group via t-tests.

  At baseline

Secondary Outcomes (4)

• Comparison of C-Reactive Protein Values

  At baseline

• Comparison of Lactoferrin Values

  At baseline

• Comparison of Calprotectin Values

  At baseline

• Comparison of Lipid Values

  At baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CF Carriers and Controls who are not CF carriers.

You may qualify if:

• A CF Carrier identified via genetic testing
• No previous CF carrier test results

You may not qualify if:

• 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

Sponsors & Collaborators

• Philip Polgreen: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be collected from all participants. Urine and/or stool samples will be collected from a subset of participants.

MeSH Terms

Conditions

Pancreatic Diseases; Kidney Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Philip M Polgreen, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip M Polgreen, MD

CONTACT

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

Shelby L Francis, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Internal Medicine

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 26, 2022
• Study Start: December 20, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)