Studying body fat and muscle and lung health in young people with cystic fibrosis
Studies how body fat and muscle relate to lung and blood sugar health.
Plain-language title generated from the registry record
Registry title: Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
Key facts
- Where
- Atlanta and Birmingham, United StatesSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for teens and adults with cystic fibrosis aged 16 and older who are clinically stable, and for healthy volunteers of similar age, sex and BMI.
- Age
- 16 years and older
- Sex
- All sexes
- Disease stage
- Cystic fibrosis confirmed by sweat test and/or CFTR genotyping with two disease-causing mutations; clinically stable. For the yearly follow-up, normal glucose tolerance on the first oral glucose tolerance test (OGTT).
- Earlier treatment
- No change in medical regimen (including medications) for at least 21 days before the study visit. Not within 1 week to 8 weeks of starting a CFTR modulator.
- Biomarker or test result
- Two disease-causing CFTR mutations and/or a positive sweat test (people with CF).
Main reasons for not taking part
- CF-related diabetes (CFRD)
- Nocturnal tube feeds
- Life expectancy under 6 months
- History of lung transplant or on the lung transplant waiting list
- Metal in the body that cannot be removed and is not safe for MRI
Read by machine on 9 November 2026.
Where in United States
- Emory University/Children's Hospital of Atlanta (CHOA)Atlanta, United StatesTaking people
- University of Alabama at Birmingham (UAB) - Children's of AlabamaBirmingham, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Emory University
- Trial code
- NCT04002882
- Record updated
- 18 May 2026
- Original description
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.Read full original descriptionShow less
Outcomes Related to Body Composition in Teens and Adults With Cystic Fibrosis (ORBIT-CF)
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.
Inclusion: CF 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; Longitudinal study inclusion:; CF participants who have normal glucose tolerance results after their initial study oral glucose tolerance test (OGTT); Healthy controls inclusion criteria:; 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: use of chronic oral corticosteroids,; malignant neoplasm (other than localized basal cell cancer of the skin) during the previous 5 years; intravenous or oral antibiotics or use of systemic corticosteroids within the past 3 weeks; diagnosis of CF-related diabetes (CFRD); history of or on waiting list for lung transplant; respiratory (including asthma), endocrine (including diabetes), autoimmune, or other chronic disease; HIV or other chronic infection; current use of any medications to treat an acute or chronic disease or illness (anti-depressants, anti-anxiety medications are acceptable),; acute illness within the past 3 weeks; CF exclusion criteria:; nocturnal tube feeds; life expectancy <6 months; un-removable metal that is incompatible with MRI; inability or unwillingness to perform major study activities (OGTT, DEXA, MRI) due to claustrophobia, fear of blood draw, or other reasons; current pregnancy or lactation; study visit falls between window of 1 week to 8 weeks of initiation of CFTR modulator; in the opinion of the CF Care Team or study physician, participant should not participate in the study, or; inability to provide informed consent or assent; Healthy controls exclusion criteria:; inability or unwillingness to perform major study activities due to claustrophobia, fear of blood draw, or other reasons; current pregnancy or lactation, or; inability to provide informed consent or assent.