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.
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.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Shelby L Francis, PhD, 319-678-8037, shelby-francis@uiowa.edu
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.
- Conditions
- Carrier State, Pancreatic Disease, Kidney Diseases
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Glucose Values
Comparison of glucose values in cystic fibrosis carrier group vs control group via t-tests.
Measured: At baseline
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)
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
Comparison of Lactoferrin Values
Comparison of lactoferrin values in cystic fibrosis carrier group vs control group via t-tests.
Measured: At baseline
Comparison of Calprotectin Values
Comparison of calprotectin values in cystic fibrosis carrier group vs control group via t-tests.
Measured: At baseline
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.
- First posted26 Jul 2022
- Study start20 Dec 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carrier StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Philip Polgreen
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor-investigator, Philip Polgreen, University of Iowa
- Investigators
- Philip M Polgreen, MD, Principal investigator, University of Iowa
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the CF Carrier State on the Kidneys and Pancreas
- ClinicalTrials.gov ID
- NCT05474417
- Acronym / sponsor ID
- 202012447
- Conditions
- Carrier State, Pancreatic Disease, Kidney Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Philip PolgreenUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- CF Carriers and Controls who are not CF carriers.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- CF patient status
- Unable to speak English
- Currently pregnant
- Unable to provide written informed consent
- Prisoner status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Glucose Values
Time frame: At baseline
Comparison of glucose values in cystic fibrosis carrier group vs control group via t-tests.
Comparison of Insulin Values
Time frame: At baseline
Comparison of insulin values in cystic fibrosis carrier group vs control group via t-tests.
4 secondary outcomes
Comparison of C-Reactive Protein Values
Time frame: At baseline
Comparison of Lactoferrin Values
Time frame: At baseline
Comparison of Calprotectin Values
Time frame: At baseline
Comparison of Lipid Values
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip M Polgreen, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
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.