Cystic Fibrosis-related DiabetesNCT03713437
Measurement of Beta Cell Death in Individuals With Cystic Fibrosis
An observational study of Cystic Fibrosis-related Diabetes, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Cystic Fibrosis-related Diabetes
- What is being tested?
- Measurement of differentially methylated insulin DNA
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 21 years
- All sexes
- Child, Adult
Study population: Subjects with CF between the age of 0 and 21 years who are at their baseline health and have not started CFTR modulator therapy within the past 6 months. Healthy, age-matched controls between 0 and 21 years of age who do not have pancreatic endocrine or exocrine dysfunction.
Who may be able to join
- 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
- Age 0 - 21 years
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital and Medical Center
Omaha, Nebraska, 68114
About this study
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.
Read the detailed description
Cystic fibrosis related diabetes (CFRD) causes increased morbidity and mortality in people with cystic fibrosis (CF). The prevalence of CFRD increases with age. While CFRD is diagnosed in only 2 percent of children under 10 year sof age, it is present in 19 percent of adolescents and up to 50 percent of adults with CF. Although CFRD is uncommon in children, recent animal and human studies have shown that milder glycemic abnormalities are common in infants and young children with CF. One of the proposed mechanisms for early glucose dysregulation in CF is related to ongoing beta cell death that may start at a very early age. The assay to be used in this study measures differentially methylated insulin DNA, released exclusively by beta cells, to determine levels of beta cell death. This assay has been shown to detect beta cell death in individuals at risk of developing type 1 diabetes. If this assay successfully detects beta cell death in individuals with CF, the investigators can identify critical time points of beta cell loss in people with CF. Understanding how and when glycemic dysregulation occurs in CF will lead to better treatment of CFRD in the future.
- Conditions
- Cystic Fibrosis-related Diabetes
- Being tested
- Measurement of differentially methylated insulin DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of differentially methylated insulin DNADiagnostic test
A serum sample will be drawn to measure differentially methylated insulin DNA.
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis | Serum sample will be drawn once Receives: Diagnostic Test: Measurement of differentially methylated insulin DNA | |
| Healthy, age-matched controls | Serum sample will be drawn once Receives: Diagnostic Test: Measurement of differentially methylated insulin DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of differentially methylated insulin DNA from infancy to early adulthood in people with cystic fibrosis
Levels of differentially methylated insulin DNA in people with CF from infancy to young adulthood will be measured and compared to levels in healthy, age-matched controls.
Measured: Level to be drawn once, usually within 3 months of recruitment into study.
Secondary outcomes (2)
Correlation between level of differentially methylated insulin DNA and oral glucose tolerance status in people with CF.
Levels of differentially methylated insulin DNA in adolescents and young adults with CF will be correlated with oral glucose tolerance status such as impaired glucose tolerance, indeterminate glucose tolerance and CFRD.
Measured: Level to be drawn once, usually within 3 months of recruitment into study.
Correlation between level of differentially methylated insulin DNA and use of CFTR modulator therapy.
Measure differences in levels of differentially methylated insulin DNA in people with CF on CFTR modulator drugs and people with CF not on modulator therapy.
Measured: Level to be drawn once, usually within 3 months of recruitment into study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start4 Apr 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis-related DiabetesStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Ashley R Deschamp, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713437
- Sponsor's protocol ID
- 0611-18-EP
- Status last verified
- Apr 2026
- First submitted
- 15 Oct 2018
- Last updated
- 7 Apr 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Beta Cell Death in Individuals With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03713437
- Acronym / sponsor ID
- 0611-18-EP
- Conditions
- Cystic Fibrosis-related Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Oct 2018 (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.
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.
Detailed description
Cystic fibrosis related diabetes (CFRD) causes increased morbidity and mortality in people with cystic fibrosis (CF). The prevalence of CFRD increases with age. While CFRD is diagnosed in only 2 percent of children under 10 year sof age, it is present in 19 percent of adolescents and up to 50 percent of adults with CF. Although CFRD is uncommon in children, recent animal and human studies have shown that milder glycemic abnormalities are common in infants and young children with CF. One of the proposed mechanisms for early glucose dysregulation in CF is related to ongoing beta cell death that may start at a very early age. The assay to be used in this study measures differentially methylated insulin DNA, released exclusively by beta cells, to determine levels of beta cell death. This assay has been shown to detect beta cell death in individuals at risk of developing type 1 diabetes. If this assay successfully detects beta cell death in individuals with CF, the investigators can identify critical time points of beta cell loss in people with CF. Understanding how and when glycemic dysregulation occurs in CF will lead to better treatment of CFRD in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis | – | Diagnostic Test: Measurement of differentially methylated insulin DNASerum sample will be drawn once |
| Healthy, age-matched controls | – | Diagnostic Test: Measurement of differentially methylated insulin DNASerum sample will be drawn once |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Subjects with CF between the age of 0 and 21 years who are at their baseline health and have not started CFTR modulator therapy within the past 6 months. Healthy, age-matched controls between 0 and 21 years of age who do not have pancreatic endocrine or exocrine dysfunction.
Key inclusion criteria (5 listed)
- 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
- Age 0 - 21 years
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of differentially methylated insulin DNAA serum sample will be drawn to measure differentially methylated insulin DNA. | Diagnostic test | Cystic Fibrosis, Healthy, age-matched controls |
Primary outcome
Levels of differentially methylated insulin DNA from infancy to early adulthood in people with cystic fibrosis
Time frame: Level to be drawn once, usually within 3 months of recruitment into study.
Levels of differentially methylated insulin DNA in people with CF from infancy to young adulthood will be measured and compared to levels in healthy, age-matched controls.
2 secondary outcomes
Correlation between level of differentially methylated insulin DNA and oral glucose tolerance status in people with CF.
Time frame: Level to be drawn once, usually within 3 months of recruitment into study.
Correlation between level of differentially methylated insulin DNA and use of CFTR modulator therapy.
Time frame: Level to be drawn once, usually within 3 months of recruitment into study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 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. This study is not recruiting at the moment.
Ashley R Deschamp, MD principal investigator
University of Nebraska
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 Cystic Fibrosis-related Diabetes, run by University of Nebraska 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 7 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of differentially methylated insulin DNA from infancy to early adulthood in people with cystic fibrosis (time frame: Level to be drawn once, usually within 3 months of recruitment into study.). 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 7 Apr 2026.