High vs Low Glycemic Index Meals for Cystic Fibrosis
Trial Summary
What is the purpose of this trial?
The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are: * Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible. * What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CF Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge.
Will I have to stop taking my current medications?
If you are currently using medications that affect blood sugar levels, you will need to stop them at least 4 weeks before joining the study. However, if you are using CFTR modulators, you can continue them as long as you've been on them for at least 2 months.
What data supports the effectiveness of the treatment High vs Low Glycemic Index Meals for Cystic Fibrosis?
Is it safe for humans to consume high or low glycemic index meals?
Research on high and low glycemic index meals, often studied in people with diabetes or insulin resistance, generally shows no significant safety concerns. These studies focus on blood sugar responses and do not report harmful effects, suggesting that these meals are safe for human consumption.678910
How is the High vs Low Glycemic Index Mixed Meal Tolerance Test treatment different from other treatments for cystic fibrosis?
This treatment is unique because it focuses on the glycemic index (GI) of meals, which measures how quickly foods raise blood sugar levels, to manage glucose and lipid metabolism in cystic fibrosis patients. Unlike standard treatments that may not consider meal composition, this approach uses high and low GI meals to potentially improve glycemic control and overall metabolic health in CF patients.13111213
Research Team
Tanicia Daley, MD, MPH
Principal Investigator
Emory University
Eligibility Criteria
This study is for adolescents and young adults with Cystic Fibrosis. It's designed to see if different types of sugar in meals affect their blood sugar levels and insulin function. Participants will be given meals with high or low glycemic index sugars, some including sugary drinks.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a randomized 2x2 factorial design evaluating acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Monitoring
Monitoring of primary and secondary outcome measures such as acceptability, retention rates, and changes in plasma markers
Treatment Details
Interventions
- High vs Low Glycemic Index Mixed Meal Tolerance Test (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator