Actively Recruiting
Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
Led by Emory University · Updated on 2025-07-22
90
Participants Needed
2
Research Sites
355 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed cystic fibrosis diagnosis by sweat test or genetic testing with two disease-causing mutations
- Age 16 years or older
- Clinically stable with no changes in medical regimen for at least 21 days before study visit
- Participation in the Cystic Fibrosis Foundation Patient Registry
- For longitudinal follow-up, CF participants must have normal glucose tolerance after initial oral glucose tolerance test
- Healthy controls must be male or female, 16 years or older, clinically stable, and similar in age, gender, and BMI to CF participants
You will not qualify if you...
- Diagnosis of cystic fibrosis-related diabetes (CFRD)
- Use of nocturnal tube feeds
- Life expectancy less than 6 months
- History of or on waiting list for lung transplant
- Presence of metal in body incompatible with MRI
- Claustrophobia, fear of blood draws, or inability/unwillingness to perform key study activities (OGTT, DEXA, MRI)
- Current pregnancy or lactation
- Study visit occurring between 1 week to 8 weeks after starting CFTR modulator treatment
- Use of chronic oral corticosteroids
- Determined by CF Care Team or study physician to be unsuitable for participation
- Inability to provide informed consent or assent
- For healthy controls: malignant neoplasm in past 5 years (except localized basal cell skin cancer)
- Chronic respiratory, endocrine, autoimmune, or other chronic diseases
- HIV or other chronic infections
- Current use of medication for acute or chronic illness (antidepressants and anti-anxiety meds allowed)
- Acute illness in past 3 weeks
- Use of intravenous or oral antibiotics or systemic corticosteroids in past 3 weeks
- Current pregnancy or lactation
- Inability to provide informed consent or assent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Alabama at Birmingham (UAB)/Children's of Alabama
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Emory University/Children's Hospital of Atlanta (CHOA)
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
S
Swati Zaveri, PhD
CONTACT
J
Jessica A Alvarez, PhD, RD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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