ORBIT-CF: Body Fat and Lung Health in Cystic Fibrosis
This observational study, ORBIT-CF, is looking at how body fat distribution affects health outcomes like blood sugar control and lung function in people with cystic fibrosis (CF) aged 16 and older. Researchers want to understand if people with CF tend to accumulate more visceral fat (fat around organs) and have less muscle compared to healthy individuals, and if this impacts their glucose tolerance and lung function. The study will measure changes in visceral fat volume using MRI, a measure of blood sugar control called Disposition Index, and lung function (FEV1%) over two years. The goal is to use this information to improve future nutrition guidance for individuals with CF. The current recruitment status is unclear.
- Study design
- This is an observational study with a planned enrollment of 90 participants, including 60 adolescents and young adults with CF and 30 volunteers without CF. A subset of 40 CF participants will be followed for two years.
- What's involved
- Participants will have detailed body composition assessments (MRI, DEXA), glucose tolerance tests, and lung health evaluations. Some CF participants will have annual study visits for two years after their initial visit.
- Compensation
- Not stated in the trial record.
- Follow-up
- A subset of participants with CF will be followed for two years after their initial visit.
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Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Jessica A Alvarez, PhD, RD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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What this trial measures
- Change in Visceral Adipose Tissue volume (VAT) by Magnetic Resonance Imaging (MRI)Baseline, 1 year, 2 year
Body fat distribution and body composition in 60 individuals with Cystic Fibrosis (CF) and 30 matched, healthy control will be assessed by Magnetic Resonance Imaging (MRI)
- Change in Disposition IndexBaseline, 1 year, 2 year
The disposition index (DI) is a measure of the ability of B-cells to compensate for insulin resistance. A lower DI indicates a loss of B-cell function, which means decreased pancreatic function. The disposition index will be assessed with an oral glucose tolerance test (OGTT) and mathematical modeling of the C-peptide and insulin response to glucose. This study seeks to determine if glucose intolerance is associated with body composition and fat distribution in CF subjects.
- Change in Forced Expiratory Volume in the first second (FEV1%)Baseline, 1 year, 2 year
Clinical spirometry is a test of lung function that will be used to assess the progression of lung disease with the baseline Forced Expiratory Volume (FEV%) predicted within the past year. Baseline is defined as the average of the best FEV1% for each quarter of the calendar year. FEV1% predicted is a method of determining the severity of pulmonary disease and declines as disease severity increases.