Evaluating how different types of meals affect blood sugar in young people with cystic fibrosis
A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis
This study is testing how different types of meals affect blood sugar levels in young people with cystic fibrosis-related diabetes to help improve their dietary choices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06350149 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of high versus low glycemic index mixed meals on glucose levels in adolescents and young adults with cystic fibrosis-related diabetes (CFRD). Participants will undergo a mixed meal tolerance test (MMTT) where blood samples will be collected before and after consuming meals that vary in glycemic index and sugar content. The study will utilize a randomized 2x2 factorial design to evaluate postprandial glucose changes and the body's insulin response. The findings could provide insights into dietary recommendations for managing CFRD.
Who should consider this trial
Good fit: Ideal candidates are adolescents and young adults with cystic fibrosis who consume a significant amount of added sugars and have pancreatic insufficiency.
Not a fit: Patients who are not English speaking, have a recent pulmonary exacerbation, or have severe lung dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary guidelines that help manage blood sugar levels in patients with cystic fibrosis-related diabetes.
How similar studies have performed: While there is ongoing research into dietary impacts on CFRD, this specific approach of comparing glycemic index effects in a mixed meal tolerance test is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * English speaking * Diagnosis of CF based on the presence of two known CF causing mutations and/or positive sweat test * Pancreatic insufficiency * Baseline dietary consumption of \>10% total kcal from added sugars and self-reported consumption of \>/= sugar-sweetened beverages per week Exclusion Criteria: * Current use or anticipated use of medication that is known to raise or lower blood glucose in the past 4 weeks. * Oral or IV glucocorticoid current or previous use in the past 4 weeks will prohibit enrollment in the study. * Recent pulmonary exacerbation within 3 weeks of enrollment and/or an acute illness requiring a change in antibiotics will also exclude participants. * BMI below the 5th percentile or greater than the 95th percentile for age and sex * FEV1 \<40% or awaiting a lung transplant; * Prior lung or liver transplant or kidney or liver dysfunction. * Use of CFTR modulators is not an exclusion criterion. Rather, for patients recently started on CFTR modulators, we will wait to enroll in the study until on CFTR modulator for at least 2 months. * Diagnosis of CF liver disease. * Uncontrolled exocrine pancreatic insufficiency/malabsorption * Diagnosis of CFRD * G-tube feeds (bolus and/or continuous) * Current enrollment in another intervention study * Changes in diet to lose or gain weight * Gluten allergy or intolerance * Current pregnancy or lactation or plans to become pregnant during study period * History of drug or alcohol abuse * Restrictive dietary patterns (e.g, vegan, ketogenic, intermittent fasting) for more than one month within the last two months prior to screening. * More than 5% body weight change within 2 months of screening visit or Day 1 of mixed meal tolerance test
Where this trial is running
Atlanta, Georgia
- Center for Advanced Pediatrics: Emory Healthcare — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Tanicia Daley, MD, MPH — Emory University
- Study coordinator: Tanicia Daley, MD, MPH
- Email: tanicia.daley@emory.edu
- Phone: 404-785-5437
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.