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Carrier StateNCT05474417

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

An observational study of Carrier State and Pancreatic Disease, run by Philip Polgreen at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Carrier State, Pancreatic Disease, Kidney Diseases
How many people
1,250 participants
Where
1 siteUnited States
Study dates
20 Dec 2021to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Adult, Older adult

Study population: CF Carriers and Controls who are not CF carriers.

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Philip M Polgreen, MD contact

(319) 384-6194

philip-polgreen@uiowa.edu

Shelby L Francis, PhD contact

319-678-8037

shelby-francis@uiowa.edu

United States1 site, 1 recruiting
  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Shelby L Francis, PhD, 319-678-8037, shelby-francis@uiowa.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

There are 2 main study components- a clinic visit (all participants) and at-home specimen collections (volunteer subsample only). Each procedure is described below.

Clinic Visit Procedures (all participants):

Height- Height will be measured to the nearest 0.5 cm. Shoes should be removed.

Weight- Weight will be measured to the nearest 0.5 kg. Shoes and any extra jackets/sweaters/layers should be removed.

Blood Pressure- Blood pressure will be measured using the following procedures- Make sure that the participant hasn't smoked for 20 minutes prior to the BP measurement. Remove all clothing that covers the location of the cuff placement. Have the participant sit comfortably in a chair, with back supported, legs uncrossed and feet flat on the floor, arm supported at the level of the heart on a table, palm facing upward. Be sure to choose a cuff that correctly fits the participant's arm size. The lower end of the cuff should be ½ to 1 inch above the inner side of the elbow joint. The middle of the cuff should be at the level of the right atrium. Place the cuff snugly around the bare upper arm so that you can only insert one finger between the cuff and the arm.

Blood Draws/2-Hour OGTT- The participant should be active and eat a regular diet for three days prior to the test. They should be instructed not to eat or drink anything except water for at least 8 hours before the test. Someone trained in phlebotomy will insert an IV into the patient's arm so that blood draws can occur before and after the oral glucose tolerance test (OGTT). They will draw 2 tubes of blood (one 3 ml lavender top tube for HbA1C and one 4.5 ml green plasma separator tube for glucose, insulin, c-peptide, and lipid values). Then, a team member will provide the participant with a chilled Fisherbrand Glucose Tolerance Test Beverage (10 oz beverage, 75 g concentration) to drink. The participant must drink the entire beverage within 5 minutes. The patient should remain seated during the 2-hours of the test. They should not eat or drink anything except for plain water during the test (no mints, cough drops, chewing gum, or smoking).

At the 1-hour mark, 1 tube of blood (4.5 ml green plasma separator tube for glucose and insulin values) will be drawn.

Once the 2 hours have passed, 2 more tubes of blood (one 3 ml lavender top tube for c-reactive protein, calprotectin, and lactoferrin and one 4.5 ml green plasma separator tube for glucose and insulin values) will be drawn.

During the downtime between blood draws, the participant will answer the questions from the baseline survey and report their current medications interview-style with the research team member.

This visit is expected to last 3-4 hours.

Home Specimen Collection (volunteer subsample only; volunteers may do urine and/or stool samples):

Participants will be given specimen collection containers and instructions on collecting the 24-hour urine sample and/or stool sample, whichever they volunteer to collect. Finally, a date, time, and meeting location will be scheduled to return the samples to the research team.

Medical subject headings
Pancreatic Diseases, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05474417
Study groupRoleWhat they receive
Cystic Fibrosis Carrier GroupParticipants who have been identified as Cystic Fibrosis Carriers via previous genetic testing.
Control GroupParticipants who have been identified as not being Cystic Fibrosis Carriers via previous genetic testing.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of Glucose Values

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

    Measured: At baseline

  2. Comparison of Insulin Values

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

    Measured: At baseline

Secondary outcomes (4)
  1. Comparison of C-Reactive Protein Values

    Comparison of c-reactive protein values in cystic fibrosis carrier group vs control group via t-tests.

    Measured: At baseline

  2. Comparison of Lactoferrin Values

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

    Measured: At baseline

  3. Comparison of Calprotectin Values

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

    Measured: At baseline

  4. Comparison of Lipid Values

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

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start20 Dec 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
1,250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05474417
Sponsor's protocol ID
202012447
Other IDs
5P30DK054759
Status last verified
Sep 2026
First submitted
22 Jul 2022
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Carrier State and Pancreatic Disease, run by Philip Polgreen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philip M Polgreen, MD ((319) 384-6194, philip-polgreen@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Glucose Values (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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