Understanding how body fat affects health in cystic fibrosis

Outcomes Related to Body Composition in Teens and Adults With Cystic Fibrosis (ORBIT-CF)

This study looks at how body fat affects health in young adults with cystic fibrosis by comparing their body composition and health to that of healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Emory University (Academic / other)
• Locations: 2 sites (Birmingham, Alabama and 1 other locations)
• Trial ID: NCT04002882 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the relationship between body fat distribution, nutrition, and health outcomes in individuals with cystic fibrosis (CF) aged 16-30. It will compare body composition and metabolic health between 60 CF patients and 30 healthy volunteers, focusing on how increased visceral fat and decreased lean body mass may impact glucose tolerance and lung function. Participants with CF will undergo detailed assessments, including MRI for fat distribution and DEXA for body composition, with a subset followed for two years to track changes over time.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 16-30 with a confirmed diagnosis of cystic fibrosis who are clinically stable.

Not a fit: Patients with cystic fibrosis-related diabetes or those requiring nocturnal tube feeds may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved nutritional monitoring and interventions that enhance health outcomes for individuals with cystic fibrosis.

How similar studies have performed: While similar studies have explored body composition in CF, this specific approach focusing on visceral fat and its impact on metabolic health is relatively novel.

Eligibility criteria

Inclusion Criteria:

CF inclusion criteria

1. confirmed CF diagnosis based on sweat testing by pilocarpine iontophoresis and/or CFTR genotyping with two disease causing mutations
2. be aged ≥ 16 yrs
3. clinically stable, defined as no changes in medical regimen (including medications) for at least 21 days prior to study visit
4. 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:

1. male or female ages 16 years and older
2. 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:

1. diagnosis of CF-related diabetes (CFRD)
2. nocturnal tube feeds
3. life expectancy \<6 months
4. history of or on waiting list for lung transplant
5. un-removable metal that is incompatible with MRI
6. inability or unwillingness to perform major study activities (OGTT, DEXA, MRI) due to claustrophobia, fear of blood draw, or other reasons
7. current pregnancy or lactation
8. study visit falls between window of 1 week to 8 weeks of initiation of CFTR modulator
9. use of chronic oral corticosteroids,
10. in the opinion of the CF Care Team or study physician, participant should not participate in the study, or
11. inability to provide informed consent or assent.

Healthy controls exclusion criteria:

1. malignant neoplasm (other than localized basal cell cancer of the skin) during the previous 5 years
2. respiratory (including asthma), endocrine (including diabetes), autoimmune, or other chronic disease
3. HIV or other chronic infection
4. current use of any medications to treat an acute or chronic disease or illness (anti-depressants, anti-anxiety medications are acceptable),
5. acute illness within the past 3 weeks
6. intravenous or oral antibiotics or use of systemic corticosteroids within the past 3 weeks
7. inability or unwillingness to perform major study activities due to claustrophobia, fear of blood draw, or other reasons
8. current pregnancy or lactation, or
9. inability to provide informed consent or assent.

Where this trial is running

Birmingham, Alabama and 1 other locations

• University of Alabama at Birmingham (UAB)/Children's of Alabama — Birmingham, Alabama, United States (Not_yet_recruiting)
• Emory University/Children's Hospital of Atlanta (CHOA) — Atlanta, Georgia, United States (Recruiting)

Study contacts

• Principal investigator: Jessica A Alvarez, PhD, RD — Emory University
• Study coordinator: Swati Zaveri, PhD

Conditions Cystic Fibrosis