Measurement of Beta Cell Death in Individuals With Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-04

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hormonal Responses to a Mixed Meal in People With Cystic Fibrosis

NCT06163482

Cystic Fibrosis

ACTIVE_NOT_RECRUITING

β-cell Function and Insulin Sensitivity in Patients With Cystic Fibrosis

NCT04379726

Cystic Fibrosis-related Diabetes

UNKNOWN

Glycemic Monitoring in Cystic Fibrosis

NCT02211235

Cystic Fibrosis

COMPLETED

Performance and Patient Acceptance of a Commercially Available Beverage as Compared to an Oral Glucose Solution for Oral Glucose Tolerance Tests in Cystic Fibrosis (CF) Patients Who Are Screened for CF-related Diabetes.

NCT05377502

Cystic Fibrosis Cystic Fibrosis-related Diabetes

UNKNOWN

Study of Hepatic Glucose Production and De Novo Lipogenesis in Patients With Cystic Fibrosis

NCT00014781

Cystic Fibrosis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis-related Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cystic Fibrosis

Serum sample will be drawn once

Measurement of differentially methylated insulin DNA

Intervention Type DIAGNOSTIC_TEST

A serum sample will be drawn to measure differentially methylated insulin DNA.

Healthy, age-matched controls

Serum sample will be drawn once

Measurement of differentially methylated insulin DNA

Intervention Type DIAGNOSTIC_TEST

A serum sample will be drawn to measure differentially methylated insulin DNA.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Measurement of differentially methylated insulin DNA

A serum sample will be drawn to measure differentially methylated insulin DNA.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

* 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

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No