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 range21 Years

SexALL

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

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