Investigating the impact of diet on diabetes risk in cystic fibrosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.