NCT06163482 Hormonal Responses to a Mixed Meal in People With Cystic Fibrosis
| NCT ID | NCT06163482 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Cincinnati |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 61 participants |
| Start Date | 2023-03-28 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 61 participants in total. It began in 2023-03-28 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with cystic fibrosis * Aged 18 to 45 years * Males and females of any race and ethnicity * Receiving highly effective CFTR modular therapy Exclusion Criteria: * 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.
Contact & Investigator
Jason Winnick, PhD
PRINCIPAL INVESTIGATOR
University of Cincinnati
Frequently Asked Questions
Who can join the NCT06163482 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06163482 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06163482 currently recruiting?
Yes, NCT06163482 is actively recruiting participants. Contact the research team at jason.winnick@uc.edu for enrollment information.
Where is the NCT06163482 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06163482 clinical trial?
NCT06163482 is sponsored by University of Cincinnati. The principal investigator is Jason Winnick, PhD at University of Cincinnati. The trial plans to enroll 61 participants.