NCT04002882 · Emory University
Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
What this study is about
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.
View original scientific 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. 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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- 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
- use of chronic oral corticosteroids,
- 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:
- malignant neoplasm (other than localized basal cell cancer of the skin) during the previous 5 years
- 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
- intravenous or oral antibiotics or use of systemic corticosteroids within the past 3 weeks
- 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.
Where
- Birmingham, Alabama
- Atlanta, Georgia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations