Status:
RECRUITING
Hormonal Responses to a Mixed Meal in People with Cystic Fibrosis
Lead Sponsor:
University of Cincinnati
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-45 years
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 a...
Detailed Description
The pancreas plays a key role in the regulation of whole-body glucose metabolism in humans. It contains 1 to 3 million islets, each of which contains several types of endocrine cells including insulin...
Eligibility Criteria
Inclusion
- Diagnosed with cystic fibrosis
- Aged 18 to 45 years
- Males and females of any race and ethnicity
- Receiving highly effective CFTR modular therapy
Exclusion
- 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.
Key Trial Info
Start Date :
March 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT06163482
Start Date
March 28 2023
End Date
December 30 2026
Last Update
January 10 2025
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0547