Investigating the impact of diet on diabetes risk in cystic fibrosis patients
Feeding Study to Optimize Endocrine Dysfunction in Cystic Fibrosis
This study is testing if a low-added sugar, high-fat diet can lower diabetes risk in adults with cystic fibrosis compared to a standard high-sugar diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05766774 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how excess dietary sugars contribute to glucose intolerance in adults with cystic fibrosis (CF), who are at high risk for CF-related diabetes (CFRD). It will compare the effects of a low-added sugar, high-fat diet against a standard high-sugar, high-fat CF diet over an 8-week period. A total of 60 participants will be randomized into two diet groups, with all meals provided. The study will assess changes in diabetes risk markers and visceral fat accumulation through various clinical evaluations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of cystic fibrosis and a high baseline intake of added sugars.
Not a fit: Patients with a confirmed diagnosis of CFRD or those with significant dietary restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations that reduce diabetes risk in patients with cystic fibrosis.
How similar studies have performed: While dietary interventions have been explored in other diabetes populations, this specific approach in cystic fibrosis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Confirmed CF diagnosis 2. Ages 18 years and older 3. Baseline estimated daily total added sugar intake \>16 tsp, as estimated from the Dietary Screener Questionnaire (DSQ). Exclusion Criteria: 1. Nocturnal tube feeds 2. BMI \<18.5 kg/m2 3. Life expectancy \< 12 months 4. Confirmed diagnosis of CFRD 5. Screening OGTT showing fasting hyperglycemia (≥126 mg/dL) 6. Chronic steroid use 7. Current pregnancy or lactation 8. Inability/unwillingness to consume the majority of foods on the menu during the study period 9. MRI-incompatible metal that cannot be removed for testing 10. Uncontrolled exocrine pancreatic insufficiency/malabsorption 11. Clinically instability, defined as no changes in medical regimen (including medications and pulmonary exacerbations) for at least 21 days prior to study visit 12. Initiation of CFTR modulator within previous 8 weeks OR unstable changes in weight and lung function due to CFTR modulator use 13. Actively trying to gain or lose weight 14. Any food allergies or intolerances that cannot be accommodated 15. Any medical condition deemed by the a study physician or PI that may preclude completion of the study or interfere with primary end points.
Where this trial is running
Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Jessica A Alvarez, PhD, RD — Emory University
- Study coordinator: Jessica A Alvarez, PhD, RD
- Email: jessica.alvarez@emory.edu
- Phone: 404-727-1390
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.