Examining hormonal responses to meals in cystic fibrosis patients
Changes in Postprandial Hormone Levels in Cystic Fibrosis Related Diabetes.
This study looks at how people with cystic fibrosis react hormonally to meals to see if these responses are linked to problems with blood sugar control.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 61 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06163482 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how individuals with cystic fibrosis respond hormonally to a mixed meal. It aims to identify correlations between these hormonal responses and impaired glucose tolerance, a common issue in this population. The study focuses on the role of pancreatic hormones, including insulin, glucagon, and somatostatin, in regulating glucose metabolism after eating. Participants will be monitored for their hormonal responses following a mixed meal to better understand the metabolic challenges faced by those with cystic fibrosis.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 45 diagnosed with cystic fibrosis who are receiving highly effective CFTR modular therapy.
Not a fit: Patients who are transplant recipients, pregnant, or have significant liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for glucose metabolism in cystic fibrosis patients.
How similar studies have performed: While this approach is exploratory, similar studies have shown promise in understanding metabolic responses in chronic conditions, though this specific focus on cystic fibrosis is less common.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cincinnati, Ohio
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jason Winnick, PhD — University of Cincinnati
- Study coordinator: Jason Winnick, PhD
- Email: jason.winnick@uc.edu
- Phone: 513-558-4437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.