Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
ConditionCystic Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorEmory University
About this trial
Nutrition and body composition, the amount of muscle and fat in the body, has a role in overall health. This study wants to learn more about how nutrition and body composition affects health outcomes like glucose tolerance and lung function in patients with cystic fibrosis (CF) who are ages 16-30 years old. 60 adolescents and young adults with CF will be recruited, and 30 volunteers without cystic fibrosis. A total of 40 of these study participants with CF will be asked to return for annual study visits for 2 years after the first visit.
The long-term goal of this study is to use the information collected to make decisions about future nutrition monitoring and interventions which help maintain optimal health for individuals with CF.
Eligibility criteria
Qualifiers
confirmed CF diagnosis based on sweat testing by pilocarpine iontophoresis and/or CFTR genotyping with two disease causing mutations
be aged ≥ 16 yrs
clinically stable, defined as no changes in medical regimen (including medications) for at least 21 days prior to study visit
participation in the CFF Patient Registry
Disqualifiers
diagnosis of CF-related diabetes (CFRD)
nocturnal tube feeds
life expectancy <6 months
history of or on waiting list for lung transplant
Trial design
Treatments tested in this trial
- Not listed
Trial groups
90 Participants
are grouped into 2 trial groupsSponsors and collaborators
Emory University
Lead sponsor
Cystic Fibrosis Foundation
Collaborator
Source ClinicalTrials.gov