Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF) (NCT04002882) | Clinical Trial Compass
RecruitingNot Applicable
Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
United States90 participantsStarted 2019-07-08
Plain-language summary
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.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. 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
✓. male or female ages 16 years and older
✓. clinically stable. Healthy controls will be recruited who are similar in age, gender, and BMI as the participants with CF.
Exclusion criteria
✕. diagnosis of CF-related diabetes (CFRD)
✕. nocturnal tube feeds
✕. life expectancy \<6 months
✕. history of or on waiting list for lung transplant
What they're measuring
1
Change in Visceral Adipose Tissue volume (VAT) by Magnetic Resonance Imaging (MRI)
Timeframe: Baseline, 1 year, 2 year
2
Change in Disposition Index
Timeframe: Baseline, 1 year, 2 year
3
Change in Forced Expiratory Volume in the first second (FEV1%)