ACTIVE_NOT_RECRUITING

Hormonal Responses to a Mixed Meal in People With Cystic Fibrosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this exploratory study, the hormonal responses to a mixed meal will be examined in people with cystic fibrosis. The aim of this study is to find correlates with impaired glucose tolerance that is associated with this population.

Official Title

Changes in Postprandial Hormone Levels in Cystic Fibrosis Related Diabetes.

Quick Facts

Study Start:2023-03-28

Study Completion:2026-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06163482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosed with cystic fibrosis * Aged 18 to 45 years * Males and females of any race and ethnicity * Receiving highly effective CFTR modular therapy	* Transplant recipient * Acute lung function decline or exacerbation within the last 3 months * Use of systemic glucocorticoids * Pregnancy * Known liver disease that would be expected to significantly impact metabolic variable as interpreted by a study doctor * The presence of any other disease or condition, as interpreted by any one of the study doctors, that would be expected to confound the responses to liquid mixed meal or make participation in the study dangerous to the individual * People who are cognitively impaired * People who do not speak English * For CFRD patients, a daily insulin requirement that exceeds 0.8 U/kg/day * Any prior history of diabetic ketoacidosis.

Inclusion Criteria

Exclusion Criteria

* Diagnosed with cystic fibrosis
* Aged 18 to 45 years
* Males and females of any race and ethnicity
* Receiving highly effective CFTR modular therapy

* Transplant recipient
* Acute lung function decline or exacerbation within the last 3 months
* Use of systemic glucocorticoids
* Pregnancy
* Known liver disease that would be expected to significantly impact metabolic variable as interpreted by a study doctor
* The presence of any other disease or condition, as interpreted by any one of the study doctors, that would be expected to confound the responses to liquid mixed meal or make participation in the study dangerous to the individual
* People who are cognitively impaired
* People who do not speak English
* For CFRD patients, a daily insulin requirement that exceeds 0.8 U/kg/day
* Any prior history of diabetic ketoacidosis.

Contacts and Locations

Principal Investigator

Jason Winnick, PhD

PRINCIPAL_INVESTIGATOR

University of Cincinnati

Study Locations (Sites)

University of Cincinnati

Cincinnati, Ohio, 45267-0547

United States

Collaborators and Investigators

Sponsor: University of Cincinnati

Jason Winnick, PhD, PRINCIPAL_INVESTIGATOR, University of Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-28

Study Completion Date2026-12-30

Study Record Updates

Study Start Date2023-03-28

Study Completion Date2026-12-30

Terms related to this study

Keywords Provided by Researchers

diabetes
cystic fibrosis

Additional Relevant MeSH Terms

Cystic Fibrosis