CompletedNot Applicable

Measurement of Beta Cell Death in Individuals With Cystic Fibrosis

United States40 participantsStarted 2019-04-04

Plain-language summary

This study evaluates the feasibility of using differentially methylated insulin DNA, a biomarker of beta cell death, in determining the time course of beta cell death and development of diabetes in people with cystic fibrosis. Study participants with cystic fibrosis and healthy control participants will have a blood sample drawn in order to measure the levels of differentially methylated insulin DNA.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for Cystic Fibrosis Subjects: * Age 0 - 21 years * Diagnosis of CF by two CF-causing mutations or elevated sweat chloride test * Normal glucose tolerance, impaired glucose tolerance, indeterminate glucose tolerance or CFRD * Pancreatic insufficiency Exclusion Criteria for Cystic Fibrosis Subjects: * Age \> 21 years * Diagnosis of type 1 or type 2 diabetes * Pregnancy * Oral or IV steroid use in the past 2 weeks * Pulmonary exacerbation requiring hospital admission in the past 2 weeks. * Initiation of CFTR corrector or potentiator medication within 6 months Inclusion Criteria for healthy, age-matched controls: * Age 0 - 21 years Exclusion Criteria for healthy, age-matched controls: * Age \> 21 years * Diagnosis of type 1 or type 2 diabetes or pre-diabetes * Disorders impacting pancreatic exocrine function * Pregnancy * Oral or IV steroid use in the past 2 weeks

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Levels of differentially methylated insulin DNA from infancy to early adulthood in people with cystic fibrosis

Timeframe: Level to be drawn once, usually within 3 months of recruitment into study.

Trial details

NCT IDNCT03713437

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Cystic Fibrosis-related Diabetes trials