Mixed Meal for Cystic Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how people with cystic fibrosis respond to eating a mixed meal, focusing on its effects on hormones. Researchers seek connections between these responses and glucose (sugar) tolerance issues, which are common in people with cystic fibrosis. Participants will be divided into groups based on diabetes status and pancreatic function. Suitable candidates for this trial include individuals diagnosed with cystic fibrosis who are currently on effective CFTR therapy (a treatment targeting the underlying cause of cystic fibrosis) and are not experiencing recent lung issues or using certain medications.
As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the understanding and treatment of cystic fibrosis.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are using systemic glucocorticoids, you cannot participate in the trial.
Is there any evidence suggesting that this trial's treatment is likely to be safe?
Research has shown that mixed meals are usually easy for people to digest, even for those with cystic fibrosis. One study compared hormonal reactions to a mixed meal in healthy individuals and those with cystic fibrosis, finding no major safety issues with the mixed meal itself.
Another small study examined a low glycemic load diet, which affects blood sugar less, in adults with cystic fibrosis who have unusual blood sugar levels. This study focused on the diet's safety and tolerability. It found no major safety problems, suggesting these dietary changes are safe for people with cystic fibrosis.
Overall, these findings suggest that mixed meals are safe and generally well-tolerated by people, including those with cystic fibrosis.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover how people with cystic fibrosis (CF), with or without diabetes or pancreatic insufficiency, respond hormonally to a mixed meal. Unlike traditional approaches that mainly focus on managing symptoms with medications like insulin or pancreatic enzyme replacements, this study could reveal underlying hormonal differences in how these groups process food. By understanding these unique responses, researchers hope to develop more personalized and effective management strategies for CF-related complications. This could lead to improved quality of life and better health outcomes for those affected by these conditions.
What evidence suggests that this trial's mixed meal treatment could be effective for cystic fibrosis?
Research has shown that people with cystic fibrosis (CF) respond differently to food compared to those without CF. They often produce less insulin, the hormone that controls blood sugar levels, especially when the pancreas doesn't make enough digestive enzymes. Consequently, managing blood sugar can be challenging. This trial will study different groups, including those with CF-related diabetes, pancreatic sufficient CF, and pancreatic insufficient CF, using mixed meals to gain a better understanding of these issues. This research is important because it could lead to improved dietary or medical treatments for people with CF, enhancing their health.25678
Who Is on the Research Team?
Jason Winnick, PhD
Principal Investigator
University of Cincinnati
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Mixed Meal Test
Participants undergo a mixed meal test to assess hormonal responses
Follow-up
Participants are monitored for safety and effectiveness after the mixed meal test
What Are the Treatments Tested in This Trial?
Interventions
- Mixed Meal
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
cystic fibrosis, but not pancreatic insufficient
cystic fibrosis and pancreatic insufficient
No cystic fibrosis (CF)
cystic fibrosis and diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Cincinnati
Lead Sponsor
Citations
Hormonal Responses to a Mixed Meal in People with ...
The aim of the current study is to examine how hormone responses to a mixed meal differ between healthy controls and people with cystic fibrosis, and how these ...
Reproducibility of in-home CFRD screening using ...
Repeated in-home CGM acquisitions show reasonable reproducibility regarding the more stringent thresholds for time >140 mg/dL and >180 mg/dL.
Early-phase insulin secretion during mixed-meal tolerance ...
Insulin secretion within 30 minutes of nutrient ingestion is reduced in people with cystic fibrosis (PwCF) and pancreatic insufficiency and ...
A Pilot and Feasibility Study to Evaluate High vs Low ...
More than 5% body weight change within 2 months of screening visit or Day 1 of mixed meal tolerance test. Study details. Conditions. Cystic ...
Decreased insulin dose-adjusted hemoglobin A1c in adults ...
A numerically significant association between ETI and IDAA1c decrease was observed in adults with established CFRD after 24 months of treatment.
Safety and tolerability of a low glycemic load dietary ...
The objective of this pilot study was to investigate the safety and tolerability of a low glycemic load (LGL) diet in adults with CF and abnormal glucose ...
Interrelationships between diet quality and health-related ...
Patient-reported outcome measures (PROMs) can yield important information about patients' perspectives on the impact of treatment on HRQoL, ...
Review Improving nutrition in cystic fibrosis: A systematic ...
In a cohort of 34 patients (mixed pediatric and adult), the program resulted in significant increases in weight and zBMI, as well as a reduction in the ...
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